Application 019860

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	TABLET;ORAL	2MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019860-001	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL		RLD, RS	1989-11-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019860-001	IMODIUM A-D	2MG	TABLET / ORAL	RLD, RS	1989-11-22	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zydus Lifesciences Limited	5d13405c-8fd7-454f-9b49-3d8b9ef672b8	2023-06-19		Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	f092b8a5-80b0-40ba-af45-2ac9edaa7704	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES	f9e03d2b-2ec0-322b-e053-6394a90a1599	2023-04-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Handy Solutions Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76e32e66-4af5-47a5-83ff-cbba206975d6	2023-03-15	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	allphamed Pharbil Arzneimittel GmbH	a8c8d1d2-a8c7-462a-b620-729a9baa93c4	2023-02-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TOP CARE (Topco Associates LLC)	c62bc8d4-0857-16fc-e053-2a95a90a0c41	2022-12-30	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
ANTI-DIARRHEAL	LOPERAMIDE HYDROCHLORIDE	Northeast Pharma	c2db4155-68d4-71be-e053-2a95a90a7f35	2022-12-30	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Premier Value Alliance LLC	0dd97bfb-67ce-472f-9b23-15f613bb3135	2022-12-29	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Wal-Mart Stores, Inc.	507acd63-b2b4-465e-bb94-2d66724de20a	2022-12-29	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	edae1ea7-7a6a-4971-8a21-c2b508e96f4e	2022-12-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
WELMATE Anti Diarrheal Loperamide HCl Softgels	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e15e9-1707-296d-e053-2995a90a1b95	2022-11-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	72a7ae47-cdf3-4949-b9f8-f29b153f787f	2022-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP, LLC	d1fd9a92-9d96-4921-b789-c1f710ee2351	2022-06-03	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Rite Aid Corporation	9cee17ca-bd11-3d40-e053-2995a90ac8fe	2022-05-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Strategic Sourcing Services LLC	1537febf-2816-438b-979a-8c8f16f06de5	2022-05-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	HEB	3ea49be2-1744-4d14-bc43-09d35fd4b3c7	2022-05-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d69532c-c71a-4880-9f74-4b37d912cabd	2022-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	82e65393-25b7-4114-9c71-5840ee8bad84	2022-05-02	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	93ebbb23-a9f0-4519-9793-c9056be39f23	2022-03-22	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	AMERISOURCE BERGEN	1a8f6a42-e74f-4725-b12e-b85c2d015191	2022-03-16	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66715-9720	Imodium AD	Loperamide Hydrochloride	Lil' Drug Store Products, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57941	SUPPL	2019-03-08
57934	SUPPL	2019-03-08
48030	SUPPL	2017-04-14
48012	SUPPL	2017-04-13
1732	SUPPL	2012-05-08
41070	SUPPL	2008-07-31
19779	SUPPL	2004-06-16
1731	SUPPL	2001-04-11