Promethazine Hydrochloride

Sold as Phenergan, Promethazine Hydrochloride Plain. Every FDA application for this active ingredient: 5 branded and 85 generic.

As of Nov 15, 2026, FDA lists 90 applications for Promethazine Hydrochloride (sold as Phenergan, Promethazine Hydrochloride Plain), first approved Mar 29, 1951, with 1 new use approved and 0 published complete response letters.

First approved: Mar 29, 1951
Applications: 90
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $18.2M
Shortage: Current

Medicare Spending

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


Promethazine HCl	Part D	$15.2M	+14%	480,046
Promethegan	Part D	$2.9M	+52%	10,919
Phenergan	Part B	$52K	-21%	9,780
Phenergan	Part D	$18K	+216%	144

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

PROMETHAZINE 12.5 MG SUPPOS: $1.98 per unitGeneric · -5% in a year
PROMETHAZINE 12.5 MG TABLET: $0.054 per unitGeneric · +9% in a year
PROMETHAZINE 25 MG SUPPOSITORY: $1.93 per unitGeneric · -9% in a year
PROMETHAZINE 25 MG TABLET: $0.046 per unitGeneric · -9% in a year
PROMETHAZINE 25 MG/ML AMPUL: $1.38 per MLGeneric · -15% in a year
PROMETHAZINE 25 MG/ML VIAL: $1.75 per MLGeneric · +1% in a year
PROMETHAZINE 50 MG TABLET: $0.085 per unitGeneric · -3% in a year
PROMETHAZINE 50 MG/ML AMPUL: $2.34 per MLGeneric · -1% in a year
PROMETHAZINE 6.25 MG/5 ML SOLN: $0.041 per MLGeneric · -7% in a year
PROMETHAZINE 6.25 MG/5 ML SYRP: $0.041 per MLGeneric · -7% in a year

Shortages

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

Shortage	Status	First posted	Updated
Promethazine Hydrochloride Injection	Current	Nov 21, 2023	Oct 14, 2026

Clinical Trials

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


A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma · Merck Sharp & Dohme LLC	Phase 2 / Phase 3	Not yet recruiting	Nov 5, 2026
Study of GI001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic LeukemiaB-Cell Non-Hodgkin Lymphoma, B-Cell Acute Lymphoblastic Leukemia · Hematology department of the 920th hospital	Early phase 1	Recruiting	Oct 7, 2026
Evaluation of GI001 for Relapsed or Refractory B-cell Non-Hodgkin LymphomaB-Cell Non-Hodgkin Lymphoma · Ruijin Hospital	Early phase 1	Not yet recruiting	May 13, 2026
Phase I Clinical Study on the Safety and Efficacy of CY-219 CAR-T Cell Injection in the Treatment of Relapsed/Refractory B-Cell LymphomaRelapsed/Refractory B-cell Lymphoma, Diffuse Large B-cell Lymphoma · Institute of Hematology & Blood Diseases Hospital, China	Phase 1	Not yet recruiting	Apr 20, 2026
Safety and Preliminary Efficacy of Hibernation-Like Therapy (Chlorpromazine and Promethazine) in Patients With Acute Ischemic Stroke (AIS) Eligible for Reperfusion Therapy.Acute Ischemic Stroke · Ji Xunming,MD,PhD	Not applicable	Not yet recruiting	Jan 23, 2026
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic AnemiaRelapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia · Yihao Wang	Phase 1 / Phase 2	Not yet recruiting	Jan 8, 2026
Histamines and Central HemodynamicsHistamine, Exercise · University of British Columbia	Not applicable	Recruiting	Dec 16, 2025
Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell LymphomaDLBCL, CLL · Institute of Hematology & Blood Diseases Hospital, China	Phase 1 / Phase 2	Recruiting	Dec 2, 2025

Applications

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


Mar 29, 1951	PhenerganNDA 7935 · New dosage form	Delcor Asset Corp	20	Discontinued
Apr 11, 1952	Promethazine Hydrochloride PlainNDA 8381 · New active ingredient	Ani Pharms	19	Discontinued
Aug 20, 1956	PhenerganNDA 8857 · New dosage form	Wyeth Ayerst	13	Discontinued
May 5, 1958	PhenerganNDA 10926 · New dosage form	Pharmobedient	15	Discontinued
Apr 27, 1960	PhenerganNDA 11689 · New formulation or manufacturer	Pharmobedient	14	Discontinued
Mar 6, 1973	Promethazine HydrochlorideANDA 83204	Watson Labs	0	Discontinued
Sep 17, 1973	Promethazine HydrochlorideANDA 83604	Ivax Sub Teva Pharms	0	Discontinued
Sep 19, 1973	Promethazine HydrochlorideANDA 83426	Watson Labs	11	Marketed
Sep 19, 1973	Promethazine HydrochlorideANDA 83312	Hikma	20	Marketed
Sep 21, 1973	Promethazine HydrochlorideANDA 83613	Ivax Sub Teva Pharms	0	Discontinued
Sep 21, 1973	Promethazine HydrochlorideANDA 83712	Watson Labs	2	Discontinued
Sep 21, 1973	Promethazine HydrochlorideANDA 83711	Watson Labs	14	Marketed
Oct 26, 1973	Promethazine HydrochlorideANDA 83603	Ivax Sub Teva Pharms	0	Discontinued
Jan 21, 1974	Promethazine HydrochlorideANDA 83838	Hospira	0	Discontinued
Jan 29, 1974	Promethazine HydrochlorideANDA 80629	Watson Labs	19	Discontinued
Aug 14, 1974	Promethazine HydrochlorideANDA 84214	Impax Labs	5	Discontinued
Feb 18, 1975	Promethazine HydrochlorideANDA 84176	Sandoz	28	Marketed
Jul 29, 1975	Promethazine HydrochlorideANDA 84554	Sun Pharm Industries	6	Discontinued
Jul 29, 1975	Promethazine HydrochlorideANDA 84557	Sun Pharm Industries	6	Discontinued
Jul 28, 1976	Promethazine HydrochlorideANDA 80949	Chartwell Molecular	2	Discontinued
Jul 29, 1976	Promethazine HydrochlorideANDA 84555	Sun Pharm Industries	6	Discontinued
Sep 9, 1976	Promethazine HydrochlorideANDA 83214	Pvt Form	0	Discontinued
Oct 1, 1976	Promethazine HydrochlorideANDA 83658	Pvt Form	0	Discontinued
Mar 3, 1977	Promethazine HydrochlorideANDA 85385	Kv Pharm	0	Discontinued
May 16, 1977	Promethazine HydrochlorideANDA 85388	Kv Pharm	0	Discontinued
Sep 26, 1977	Promethazine HydrochlorideANDA 85684	Watson Labs	0	Discontinued
Aug 21, 1978	Prometh PlainANDA 85953	Actavis Mid Atlantic	27	Discontinued
Sep 15, 1978	Promethazine HydrochlorideANDA 84591	Watson Labs	14	Discontinued
Nov 14, 1978	Prometh FortisANDA 84772	Alpharma US Pharms	4	Discontinued
Nov 21, 1978	Zipan-25, Zipan-50ANDA 83997	Altana	0	Discontinued
Oct 5, 1981	PromethaconANDA 84901	Polymedica	0	Discontinued
Oct 5, 1981	PromethaconANDA 84902	Polymedica	0	Discontinued
Nov 15, 1982	Promethazine PlainANDA 87953	Pharmobedient	21	Marketed
Jan 18, 1983	Mymethazine FortisANDA 87996	Usl Pharma	0	Discontinued
Sep 10, 1985	Promethazine HydrochlorideANDA 89109	Teva	2	Discontinued
Aug 14, 1987	PrometheganANDA 87165	Cosette Pharms Nc	11	Marketed
May 2, 1988	Promethazine HydrochlorideANDA 89463	Marsam Pharms LLC	1	Discontinued
May 2, 1988	Promethazine HydrochlorideANDA 89477	Marsam Pharms LLC	1	Discontinued
Sep 16, 1994	Promethazine HydrochlorideANDA 85146	Rising	1	Discontinued
Sep 25, 1998	Promethazine HydrochlorideANDA 40026	Chartwell Rx	5	Marketed
Jun 8, 2000	Promethazine HydrochlorideANDA 40372	Hospira	8	Discontinued
Feb 5, 2002	Promethazine HydrochlorideANDA 40428	Cosette Pharms Nc	11	Marketed
Aug 22, 2002	Promethazine HydrochlorideANDA 40454	Teva Pharms USA	3	Discontinued
Nov 21, 2002	Promethazine HydrochlorideANDA 40471	Mylan Institutional	1	Discontinued
Feb 27, 2003	Promethazine HydrochlorideANDA 40449	Able	2	Discontinued
Mar 19, 2003	Promethazine HydrochlorideANDA 40515	Am Regent	3	Discontinued
Apr 11, 2003	Promethazine HydrochlorideANDA 40504	Able	2	Discontinued
Jun 24, 2003	Promethazine HydrochlorideANDA 40479	Watson Labs Inc	1	Discontinued
Jun 30, 2003	Promethazine HydrochlorideANDA 40500	Padagis Israel	1	Marketed
Mar 17, 2004	Promethazine HydrochlorideANDA 40524	Bedford Labs	0	Discontinued
Jul 1, 2004	Promethazine HydrochlorideANDA 40558	Able	1	Discontinued
Nov 18, 2005	Promethazine HydrochlorideANDA 40596	Zydus Pharms USA	1	Marketed
Apr 26, 2006	Promethazine HydrochlorideANDA 40643	Pharm Assoc	1	Marketed
Jul 18, 2006	Promethazine HydrochlorideANDA 40622	Prinston	0	Marketed
Jul 31, 2006	Promethazine HydrochlorideANDA 40713	Kvk Tech	0	Marketed
Jul 31, 2006	Promethazine HydrochlorideANDA 40712	Kvk Tech	6	Marketed
Oct 26, 2006	Promethazine HydrochlorideANDA 40603	Sun Pharma Canada	0	Discontinued
Nov 8, 2006	Promethazine HydrochlorideANDA 40593	Sandoz	0	Discontinued
Apr 4, 2007	Promethazine HydrochlorideANDA 40718	Sun Pharma Canada	0	Discontinued
Mar 5, 2008	Promethazine HydrochlorideANDA 40673	Quagen	1	Marketed
Apr 24, 2008	Promethazine HydrochlorideANDA 40737	Xgen Pharms	2	Marketed
May 20, 2008	Promethazine HydrochlorideANDA 40791	Impax Labs	0	Discontinued
Sep 26, 2008	Promethazine HydrochlorideANDA 40785	Wockhardt Bio AG	2	Discontinued
Dec 30, 2008	Promethazine HydrochlorideANDA 40863	Sun Pharm Inds Inc	0	Discontinued
Mar 13, 2009	Promethazine HydrochlorideANDA 40891	Strides Pharma	0	Marketed
Dec 30, 2009	Promethazine HydrochlorideANDA 40882	Amneal Pharms	0	Discontinued
Dec 13, 2010	Promethazine HydrochlorideANDA 91179	Amneal Pharms Ny	0	Marketed
Aug 30, 2011	Promethazine HydrochlorideANDA 91054	Aurobindo Pharma USA	1	Discontinued
Jun 28, 2012	Promethazine HydrochlorideANDA 91675	Cosette Pharms Nc	0	Marketed
Jun 30, 2017	Promethazine HydrochlorideANDA 209177	Strides Pharma	0	Discontinued
Jul 12, 2021	Promethazine HydrochlorideANDA 213890	Quagen	0	Marketed
Nov 2, 2022	Promethazine HydrochlorideANDA 216446	Annora Pharma	0	Marketed
—	Promethazine HydrochlorideANDA 85986	Watson Labs	1	Discontinued
—	RemsedANDA 83176	Bristol Myers Squibb	0	Discontinued
—	Promethazine HydrochlorideANDA 83401	Watson Labs	0	Discontinued
—	Promethazine HydrochlorideANDA 83403	Watson Labs	0	Discontinued
—	Promethazine HydrochlorideANDA 83532	Watson Labs	0	Discontinued
—	Promethazine HydrochlorideANDA 83955	Epic Pharma LLC	0	Discontinued
—	Promethazine HydrochlorideANDA 84027	Tablicaps	0	Discontinued
—	Promethazine HydrochlorideANDA 84080	Tablicaps	0	Discontinued
—	Promethazine HydrochlorideANDA 84160	Abbott	0	Discontinued
—	Promethazine HydrochlorideANDA 84166	Abbott	0	Discontinued
—	Promethazine HydrochlorideANDA 84222	Abbott	0	Discontinued
—	Promethazine HydrochlorideANDA 84223	Abbott	0	Discontinued
—	Promethazine HydrochlorideANDA 84233	Rising	2	Discontinued
—	Promethazine HydrochlorideANDA 84539	Abbott	0	Discontinued
—	Promethazine HydrochlorideANDA 85664	Watson Labs	1	Discontinued
—	Promethazine HydrochlorideANDA 86395	Whiteworth Town Plsn	0	Discontinued
—	Promethazine HydrochlorideANDA 87518	Pharm Assoc	0	Discontinued
—	PromethazineANDA 89013	Cenci	0	Discontinued

Show all 90

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