Propranolol Hydrochloride

Manages hypertension. Sold as Inderal, Propranolol Hydrochloride, Inderal La, Innopran Xl, Hemangeol. Every FDA application for this active ingredient: 6 branded and 126 generic.

As of Nov 15, 2026, FDA lists 132 applications for Propranolol Hydrochloride (sold as Inderal, Propranolol Hydrochloride, Inderal La and others), first approved Nov 13, 1967, with 9 new uses approved and 0 published complete response letters.

First approved: Nov 13, 1967
Applications: 132
New uses approved: 9
Complete response letters: 0
Medicare spending, 2025: $104M
First approved in the EU: Apr 23, 2014
Shortage: Current

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Propranolol HCl	Part D	$52.7M	-1%	787,477
Propranolol HCl ER	Part D	$41.9M	-12%	298,060
Inderal La	Part D	$6.0M	-17%	230
Innopran XL	Part D	$2.4M	-13%	176
Inderal XL	Part D	$914K	-15%	79

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PROPRANOLOL 10 MG TABLET: $0.046 per unitGeneric · -9% in a year
PROPRANOLOL 20 MG TABLET: $0.049 per unitGeneric · -17% in a year
PROPRANOLOL 20 MG/5 ML SOLN: $0.091 per MLGeneric · -1% in a year
PROPRANOLOL 40 MG TABLET: $0.077 per unitGeneric · -2% in a year
PROPRANOLOL 40 MG/5 ML SOLN: $0.133 per MLGeneric · new this year
PROPRANOLOL 60 MG TABLET: $0.157 per unitGeneric · +13% in a year
PROPRANOLOL 80 MG TABLET: $0.155 per unitGeneric · +4% in a year
PROPRANOLOL ER 120 MG CAPSULE: $0.206 per unitGeneric · +2% in a year
PROPRANOLOL ER 160 MG CAPSULE: $0.309 per unitGeneric · -3% in a year
PROPRANOLOL ER 60 MG CAPSULE: $0.168 per unitGeneric · -5% in a year
PROPRANOLOL ER 80 MG CAPSULE: $0.185 per unitGeneric · -5% in a year
INDERAL XL 80 MG CAPSULE: $68.59 per unitBrand · -1% in a year

Orphan Designations (FDA)

2 designations, 1 approved for the designated use; see all orphan designations

Treatment of retinopathy of prematurityRecordati Rare Diseases, SARL · designated Aug 23, 2019
Treatment of proliferating infantile hemangiomas requiring systemic therapyEton Pharmaceuticals, Inc. · designated Sep 5, 2008 · approved Mar 14, 2014

Approvals in the EU (EMA)

First approved in the EU 557 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Hemangiol, new substancePierre Fabre Medicament · Apr 23, 2014

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Hemangiol, new approvalA drug with a new indication in a new dosage form indicated for the treatment of infantile hemangioma. · Maruho Co., Ltd. · Jul 4, 2016 · Review report
InderalDrugs with a new additional indication and a new dosage for the prevention of hypoxic attack caused by right ventricular outflow tract obstruction. · AstraZeneca K.K. · Nov 18, 2014
InderalDrugs with a new additional indication and a new dosage for the prevention of migraine attack. · AstraZeneca K.K. · Feb 28, 2013
InderalDrugs with new additional pediatric dosages for extrasystole (supraventricular/ventricular), the prevention of paroxysmal tachycardia, atrial fibrillation… · AstraZeneca K.K. · May 25, 2012

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Propranolol Hydrochloride Injection	Current	Oct 31, 2023	Nov 3, 2026

Clinical Trials

84 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind StudyTraumatic Brain Injury (TBI) Patients · Fundació d'investigació Sanitària de les Illes Balears	Phase 3	Recruiting	Oct 27, 2026
Propranolol Hydrochloride Combined With Adebrelimab and Platinum-Based Chemotherapy in Small Cell Lung CancerSmall Cell Lung Cancer (SCLC) · Second Xiangya Hospital of Central South University	Phase 1	Recruiting	Oct 21, 2026
Propranolol Hydrochloride Combined With Toripalimab and Platinum-based Chemotherapy in Resectable Non-Small Cell Lung CancerResectable Non-Small-Cell Lung Cancer · Second Xiangya Hospital of Central South University	Phase 1	Recruiting	Oct 21, 2026
Efficacy of Cognitive Behavioral Therapy at Vestibular MigraineCognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine · Sohag University	Not applicable	Not yet recruiting	Sep 30, 2026
Multiple Adjunct Therapies to Improve Immunotherapy Treatment in Patients With Locally Advanced or Metastatic Melanoma or Advanced Hepatocellular CancerAdvanced Hepatocellular Carcinoma, Advanced Melanoma · University of Southern California	Phase 2	Not yet recruiting	Sep 23, 2026
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using PropranololPost-Traumatic Stress Disorder, PTSD · University Hospital, Toulouse	Phase 3	Not yet recruiting	Aug 28, 2026
Preventive Role of Melatonin and Propranolol Administration in Pediatric MigraineMigraine Disorders · Nishtar Medical University	Not applicable	Enrolling by invitation	Aug 3, 2026
Neoadjuvant Propranolol Plus SOX and Toripalimab for Locally Advanced Gastric/GEJ AdenocarcinomaGastric or Gastroesophageal Junction Adenocarcinoma, Propranolol · Ting Liu	Phase 1 / Phase 2	Not yet recruiting	Jul 27, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 13, 1967	InderalNDA 16418 · New molecular entity	Wyeth Pharms	54	Discontinued
Nov 13, 1967	Propranolol HydrochlorideNDA 16419 · New dosage form	Baxter Hlthcare Corp	17	Discontinued
Apr 19, 1983	Inderal LaNDA 18553 · New dosage form	Ani Pharms	35	Marketed
Jul 30, 1985	Propranolol HydrochlorideANDA 70125	Dava Pharms Inc	4	Discontinued
Jul 30, 1985	Propranolol HydrochlorideANDA 70127	Dava Pharms Inc	4	Discontinued
Aug 6, 1985	Propranolol HydrochlorideANDA 70120	Schering	1	Discontinued
Aug 6, 1985	Propranolol HydrochlorideANDA 70121	Schering	1	Discontinued
Aug 6, 1985	Propranolol HydrochlorideANDA 70122	Schering	1	Discontinued
Aug 6, 1985	Propranolol HydrochlorideANDA 70124	Schering	1	Discontinued
Sep 9, 1985	Propranolol HydrochlorideANDA 70306	Duramed Pharms Barr	3	Discontinued
Sep 9, 1985	Propranolol HydrochlorideANDA 70307	Duramed Pharms Barr	3	Discontinued
Sep 9, 1985	Propranolol HydrochlorideANDA 70308	Duramed Pharms Barr	3	Discontinued
Sep 9, 1985	Propranolol HydrochlorideANDA 70310	Duramed Pharms Barr	2	Discontinued
Nov 19, 1985	Propranolol HydrochlorideANDA 70213	Mylan	19	Marketed
Apr 11, 1986	Propranolol HydrochlorideANDA 70549	Watson Labs Teva	10	Discontinued
Apr 11, 1986	Propranolol HydrochlorideANDA 70550	Watson Labs Teva	10	Discontinued
Apr 14, 1986	Propranolol HydrochlorideANDA 70221	Ph Health	14	Marketed
May 13, 1986	Propranolol HydrochlorideANDA 70176	Watson Labs	20	Marketed
May 13, 1986	Propranolol HydrochlorideANDA 70177	Watson Labs	19	Marketed
May 13, 1986	Propranolol HydrochlorideANDA 70178	Watson Labs	21	Marketed
May 13, 1986	Propranolol HydrochlorideANDA 70175	Watson Labs	20	Marketed
Jun 13, 1986	Propranolol HydrochlorideANDA 70663	Chartwell Rx	15	Discontinued
Jun 13, 1986	Propranolol HydrochlorideANDA 70667	Chartwell Rx	15	Discontinued
Jun 13, 1986	Propranolol HydrochlorideANDA 70664	Chartwell Rx	15	Discontinued
Jun 13, 1986	Propranolol HydrochlorideANDA 70665	Chartwell Rx	15	Discontinued
Jun 23, 1986	Propranolol HydrochlorideANDA 70233	Teva	1	Discontinued
Jun 23, 1986	Propranolol HydrochlorideANDA 70234	Teva	1	Discontinued
Jul 7, 1986	Propranolol HydrochlorideANDA 70516	Roxane	5	Discontinued
Jul 7, 1986	Propranolol HydrochlorideANDA 70517	Roxane	5	Discontinued
Jul 7, 1986	Propranolol HydrochlorideANDA 70518	Roxane	5	Discontinued
Jul 10, 1986	Propranolol HydrochlorideANDA 70548	Watson Labs Teva	13	Discontinued
Jul 10, 1986	Propranolol HydrochlorideANDA 70551	Watson Labs	13	Discontinued
Aug 1, 1986	Propranolol HydrochlorideANDA 70219	Vintage Pharms	4	Marketed
Aug 4, 1986	Propranolol HydrochlorideANDA 70322	Innogenix	14	Marketed
Sep 11, 1986	Propranolol HydrochlorideANDA 70519	Roxane	6	Discontinued
Sep 11, 1986	Propranolol HydrochlorideANDA 70521	Roxane	6	Discontinued
Oct 1, 1986	Propranolol HydrochlorideANDA 70309	Duramed Pharms Barr	1	Discontinued
Oct 1, 1986	Propranolol HydrochlorideANDA 71327	Duramed Pharms Barr	1	Discontinued
Oct 6, 1986	Propranolol HydrochlorideANDA 71098	Watson Labs	4	Discontinued
Oct 6, 1986	Propranolol HydrochlorideANDA 71183	Watson Labs	4	Discontinued
Oct 10, 1986	Propranolol HydrochlorideANDA 70666	Chartwell Rx	14	Discontinued
Oct 22, 1986	Propranolol HydrochlorideANDA 71288	Aiping Pharm Inc	11	Discontinued
Oct 29, 1986	Propranolol HydrochlorideANDA 70123	Schering	1	Discontinued
Dec 12, 1986	InderalNDA 19536 · New dosage form	Wyeth Ayerst	2	Discontinued
May 5, 1987	Propranolol HydrochlorideANDA 71370	Interpharm	0	Discontinued
May 5, 1987	Propranolol HydrochlorideANDA 71371	Interpharm	0	Discontinued
May 5, 1987	Propranolol HydrochlorideANDA 71368	Interpharm	0	Discontinued
May 5, 1987	Propranolol HydrochlorideANDA 71369	Interpharm	0	Discontinued
May 15, 1987	Propranolol HydrochlorideANDA 70690	Hikma	17	Marketed
May 15, 1987	Propranolol Hydrochloride IntensolANDA 71388	Roxane	11	Discontinued
Jul 15, 1987	Propranolol HydrochlorideANDA 71791	Ani Pharms	9	Discontinued
Jul 15, 1987	Propranolol HydrochlorideANDA 71792	Watson Labs	8	Discontinued
Oct 7, 1987	Propranolol HydrochlorideANDA 70232	Teva	1	Discontinued
Apr 6, 1988	Propranolol HydrochlorideANDA 71972	Impax Labs Inc	14	Marketed
Apr 6, 1988	Propranolol HydrochlorideANDA 71976	Impax Labs Inc	14	Marketed
Apr 6, 1988	Propranolol HydrochlorideANDA 71977	Ani Pharms	9	Discontinued
Jun 8, 1988	Propranolol HydrochlorideANDA 71517	Superpharm	4	Discontinued
Jun 8, 1988	Propranolol HydrochlorideANDA 71518	Superpharm	4	Discontinued
Apr 11, 1989	Propranolol HydrochlorideANDA 72499	Inwood Labs	8	Discontinued
Apr 11, 1989	Propranolol HydrochlorideANDA 72500	Inwood Labs	8	Discontinued
Apr 11, 1989	Propranolol HydrochlorideANDA 72501	Inwood Labs	8	Discontinued
Apr 11, 1989	Propranolol HydrochlorideANDA 72502	Inwood Labs	9	Discontinued
Aug 29, 2000	Propranolol HydrochlorideANDA 75792	Chartwell Injectable	4	Discontinued
Aug 31, 2001	Propranolol HydrochlorideANDA 75826	Fresenius Kabi USA	5	Marketed
Feb 26, 2003	Propranolol HydrochlorideANDA 76400	Sciegen Pharms	1	Discontinued
Mar 12, 2003	Innopran XlNDA 21438 · New formulation or manufacturer	Ani Pharms	9	Marketed
Jan 26, 2007	Propranolol HydrochlorideANDA 78065	Anda Repository	1	Marketed
Feb 15, 2007	Propranolol HydrochlorideANDA 78022	Chartwell Rx	2	Discontinued
Aug 10, 2007	Propranolol HydrochlorideANDA 78494	Actavis Elizabeth	3	Marketed
Jan 10, 2008	Propranolol HydrochlorideANDA 78213	Northstar Hlthcare	5	Discontinued
Jan 31, 2008	Propranolol HydrochlorideANDA 77760	Hikma Farmaceutica	1	Marketed
Jun 2, 2008	Propranolol HydrochlorideANDA 78955	Ipca Labs Ltd	1	Marketed
Mar 6, 2009	Propranolol HydrochlorideANDA 78311	Upsher Smith Labs	1	Discontinued
Mar 25, 2011	Propranolol HydrochlorideANDA 90321	Zydus Pharms USA Inc	0	Marketed
Jul 15, 2011	Propranolol HydrochlorideANDA 78703	Adare Pharms Inc	1	Marketed
Mar 14, 2014	HemangeolNDA 205410 · New formulation or manufacturer	Eton	5	Marketed
Jan 6, 2020	Propranolol HydrochlorideANDA 212026	Amta	1	Marketed
Jan 12, 2024	Propranolol HydrochlorideANDA 204349	Lupin	0	Discontinued
Jan 27, 2026	Propranolol HydrochlorideANDA 216663	Mankind Pharma	0	Marketed
May 1, 2026	Propranolol HydrochlorideANDA 203103	Ipca Labs Ltd	0	Marketed
Jun 10, 2026	Propranolol HydrochlorideANDA 219165	Pai Holdings	0	Marketed
Jun 24, 2026	Propranolol HydrochlorideANDA 217238	Micro Labs	0	Marketed
Aug 14, 2026	Propranolol HydrochlorideANDA 219460	Creekwood Pharms	0	Marketed
Oct 26, 2026	Propranolol HydrochlorideANDA 216072	Senores Pharms	0	Marketed
—	Propranolol HydrochlorideANDA 70135	Smith And Nephew	0	Discontinued
—	Propranolol HydrochlorideANDA 70136	Solopak	0	Discontinued
—	Propranolol HydrochlorideANDA 70137	Smith And Nephew	0	Discontinued
—	Propranolol HydrochlorideANDA 70140	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70141	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70142	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70143	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70144	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70378	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70379	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70380	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70381	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 70382	Watson Labs	0	Discontinued
—	Propranolol HydrochlorideANDA 71496	Dava Pharms Inc	0	Discontinued
—	Propranolol HydrochlorideANDA 71687	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 71688	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 71689	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 72068	Ivax Sub Teva Pharms	0	Discontinued
—	Propranolol HydrochlorideANDA 72069	Ivax Sub Teva Pharms	0	Discontinued
—	Propranolol HydrochlorideANDA 72117	Lederle	0	Discontinued
—	Propranolol HydrochlorideANDA 72118	Lederle	0	Discontinued
—	Propranolol HydrochlorideANDA 72119	Lederle	0	Discontinued
—	Propranolol HydrochlorideANDA 72120	Lederle	0	Discontinued
—	Propranolol HydrochlorideANDA 70126	Dava Pharms Inc	0	Discontinued
—	Propranolol HydrochlorideANDA 70128	Dava Pharms Inc	0	Discontinued
—	Propranolol HydrochlorideANDA 70438	Warner Chilcott	0	Discontinued
—	Propranolol HydrochlorideANDA 70439	Warner Chilcott	0	Discontinued
—	Propranolol HydrochlorideANDA 70440	Warner Chilcott	0	Discontinued
—	Propranolol HydrochlorideANDA 70441	Warner Chilcott	0	Discontinued
—	Propranolol HydrochlorideANDA 70442	Warner Chilcott	0	Discontinued
—	Propranolol HydrochlorideANDA 70520	Roxane	0	Discontinued
—	Propranolol HydrochlorideANDA 70757	Purepac Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 70814	Purepac Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 70815	Purepac Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 70816	Purepac Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 70817	Purepac Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 71495	Dava Pharms Inc	0	Discontinued
—	Propranolol HydrochlorideANDA 71515	Superpharm	0	Discontinued
—	Propranolol HydrochlorideANDA 71516	Superpharm	0	Discontinued
—	Propranolol HydrochlorideANDA 71658	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 71984	Pai Holdings Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 71985	Pai Holdings Pharm	0	Discontinued
—	Propranolol HydrochlorideANDA 72063	Ivax Sub Teva Pharms	0	Discontinued
—	Propranolol HydrochlorideANDA 72066	Ivax Sub Teva Pharms	0	Discontinued
—	Propranolol HydrochlorideANDA 72067	Ivax Sub Teva Pharms	0	Discontinued
—	Propranolol HydrochlorideANDA 72197	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 72198	Sandoz	0	Discontinued
—	Propranolol HydrochlorideANDA 72275	Mylan	0	Discontinued

Show all 132

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA