Loperamide Hydrochloride

Sold as Imodium, Imodium A-D, Imodium A-D Ez Chews, Loperamide Hydrochloride. Every FDA application for this active ingredient: 7 branded and 32 generic.

As of Nov 15, 2026, FDA lists 39 applications for Loperamide Hydrochloride (sold as Imodium, Imodium A-D, Imodium A-D Ez Chews and others), first approved Dec 28, 1976, with 1 new use approved and 0 published complete response letters.

First approved: Dec 28, 1976
Applications: 39
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $15.1M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Loperamide	Part D	$15.1M	-11%	460,205

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

LOPERAMIDE 2 MG CAPSULE: $0.058 per unitGeneric · -11% in a year

Clinical Trials

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


Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)Pouch, Ileal, Pouches, Ileoanal · University of North Carolina, Chapel Hill	Phase 4	Not yet recruiting	Aug 10, 2026
Rash & Diarrhea Prophylaxis With CapivasertibMetastatic HR+/HER2- Breast Cancer · Maryam Lustberg	Phase 2	Recruiting	Feb 23, 2026
Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive ChemoradiotherapyEsophageal Squamous Cell Carcinoma (ESCC) · Ye jinjun	Phase 3	Enrolling by invitation	Jun 12, 2025
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer PatientsLow Anterior Resection Syndrome, Rectal Carcinoma · Ohio State University Comprehensive Cancer Center	Not applicable	Recruiting	May 22, 2024
Antibiotics and Vaccine Immune Responses StudyVaccine Response Impaired · South Australian Health and Medical Research Institute	Phase 4	Recruiting	Nov 28, 2023
Multi-System Analysis of Opioid Receptor BindingHealthy, Opioid Use Disorder · University of Pennsylvania	Phase 1	Active, not recruiting	Sep 6, 2022
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant NeratinibEarly-stage Breast Cancer, HER2 Positive Breast Cancer · Spanish Breast Cancer Research Group	Phase 2	Active, not recruiting	Feb 23, 2022

Applications

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


Dec 28, 1976	ImodiumNDA 17690 · New formulation or manufacturer	J And J Consumer Inc	5	Discontinued
Dec 28, 1976	ImodiumNDA 17694 · New molecular entity	J And J Consumer Inc	46	Discontinued
Jul 31, 1984	ImodiumNDA 19037 · New dosage form	Janssen Pharms	3	Discontinued
Mar 1, 1988	Imodium A-DNDA 19487 · New formulation or manufacturer	Kenvue Brands	23	Marketed
Nov 22, 1989	Imodium A-DNDA 19860 · New dosage form	Kenvue Brands	22	Marketed
Aug 30, 1991	Loperamide HydrochlorideANDA 73122	Teva	16	Discontinued
Sep 18, 1991	Loperamide HydrochlorideANDA 72741	Mylan	7	Marketed
Jan 21, 1992	Loperamide HydrochlorideANDA 73243	Perrigo	10	Discontinued
Apr 30, 1992	Loperamide HydrochlorideANDA 73079	Allied	5	Discontinued
Apr 30, 1992	Loperamide HydrochlorideANDA 73192	Teva	21	Marketed
Aug 28, 1992	Loperamide HydrochlorideANDA 72993	Chartwell Rx	9	Discontinued
Sep 15, 1992	Loperamide HydrochlorideANDA 73187	Alpharma US Pharms	0	Discontinued
Oct 30, 1992	Loperamide HydrochlorideANDA 74194	Perrigo	6	Discontinued
Dec 10, 1992	Loperamide HydrochlorideANDA 74091	Ohm Labs	13	Marketed
Jul 30, 1993	Loperamide HydrochlorideANDA 73254	Contract Pharmacal	9	Discontinued
Nov 30, 1993	Loperamide HydrochlorideANDA 73528	Able	0	Discontinued
Jun 23, 1995	Loperamide HydrochlorideANDA 73478	Teva	1	Discontinued
Nov 17, 1995	Loperamide HydrochlorideANDA 74352	Pai Holdings	3	Discontinued
Jul 24, 1997	Imodium A-D Ez ChewsNDA 20448 · New dosage form	J And J Consumer Inc	7	Discontinued
Aug 28, 1997	Loperamide HydrochlorideANDA 74730	Wockhardt Bio AG	0	Discontinued
Dec 29, 1997	Loperamide HydrochlorideANDA 74991	Duramed Pharms Barr	0	Discontinued
Jan 6, 2000	Loperamide HydrochlorideANDA 75232	L Perrigo Co	9	Marketed
Jun 10, 2003	Loperamide HydrochlorideANDA 76497	Lnk	2	Marketed
Aug 4, 2005	Loperamide HydrochlorideNDA 21855 · New dosage form	Bionpharma	4	Marketed
May 20, 2011	Loperamide HydrochlorideANDA 91292	Perrigo R And D	4	Marketed
Dec 15, 2015	Loperamide HydrochlorideANDA 206548	Aurobindo Pharma	5	Marketed
Aug 11, 2021	Loperamide HydrochlorideANDA 213070	Onesource	0	Marketed
Oct 6, 2021	Loperamide HydrochlorideANDA 215001	Edenbridge Pharms	0	Marketed
Oct 22, 2021	Loperamide HydrochlorideANDA 215579	Bionpharma	0	Marketed
Jan 26, 2023	Loperamide HydrochlorideANDA 216876	Rubicon Research	0	Marketed
Mar 23, 2023	Loperamide HydrochlorideANDA 217471	Zydus Lifesciences	0	Marketed
Jul 5, 2023	Loperamide HydrochlorideANDA 217840	Jubilant Cadista	0	Marketed
Sep 5, 2023	Loperamide HydrochlorideANDA 218122	Aurobindo Pharma Ltd	0	Marketed
Sep 19, 2025	Loperamide HydrochlorideANDA 220100	Bionpharma	0	Marketed
Nov 17, 2025	Loperamide HydrochlorideANDA 220153	Pharmazone	0	Marketed
Dec 29, 2025	Loperamide HydrochlorideANDA 220372	Aurobindo Pharma	0	Marketed
Sep 30, 2026	Loperamide HydrochlorideANDA 220722	Taro	0	Marketed
—	Loperamide HydrochlorideANDA 73062	Watson Labs	0	Discontinued
—	Loperamide HydrochlorideANDA 73080	Roxane	0	Discontinued

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