Application 076497

Type: ANDA
Sponsor: LNK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A076497-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2003-06-10

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`3a93d1ddd44b…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-diarrheal	LOPERAMIDE HCL	Chain Drug Consortium	1b82f4ce-0cf5-46d1-9894-9f1271b29569	2025-07-21	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 68016-301
Anti-Diarrheal, 24/7 Life by 7-Eleven	LOPERAMIDE HCL TABLET	Lil' Drug Store Products, Inc.	37ed75fd-fa8d-2a52-e063-6294a90a7009	2025-06-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Geri-Care Pharmaceutical Corp	0ecca2cd-c971-47b2-a2ac-ae7842dd4264	2025-06-11	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 57896-381
Anti Diarrheal	LOPERAMIDE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	3d2d211f-546b-48fe-b47c-d4a254f952a3	2025-02-03	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 63868-559
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Advanced Rx LLC	287bd6d9-aa29-4f56-9c7f-5cbacbf62537	2024-08-11	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	SDA Laboratories, Inc.	d954ff63-f096-45e8-a0b6-f22e323b113f	2024-04-18	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti Diarrheal	LOPERAMIDE HCL	WinCo Foods	3ec4c6c7-c297-4ae4-b275-4c015e922bec	2022-01-06	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 67091-405
Anti-Diarrheal	MARC GLASSMAN	Marc Glassman, Inc.	ff8719b7-4283-4e2c-baf6-65f250f48938	2020-09-01	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
WELMATE Anti Diarrheal Loperamide HCl	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e006c-0347-6c35-e053-2a95a90ab7b1	2020-08-31	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	First Aid Direct	952fa976-ac4c-4dfb-b689-12c5242498ac	2019-09-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 53117-248
Anti-Diarrheal	LOPERAMIDE HCL	Allegiant Health	aca3742c-2a82-4e91-8aaf-2fce08487e56	2017-11-13	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497

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 2 of 3 · 177 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-753	Anti Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
53117-248	Anti-Diarrheal	Loperamide HCl	First Aid Direct	ANDA	Current
53117-248	Anti-Diarrheal	Loperamide HCl	First Aid Direct	ANDA	Current
53943-375	Anti-Diarrheal	Loperamide HCl	Discount Drug Mart	ANDA	Current
53943-375	Anti-Diarrheal	Loperamide HCl	Discount Drug Mart	ANDA	Current
53943-375	Anti-Diarrheal	Loperamide HCl	Discount Drug Mart	ANDA	Current
53943-375	Anti-Diarrheal	Loperamide HCl	Discount Drug Mart	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55301-375	Anti Diarrheal	Loperamide HCl	ARMY AND AIR FORCE EXCHANGE SERVICE	ANDA	Current
55315-975	Anti-Diarrheal	Loperamide HCl	FRED'S, INC.	ANDA	Current
55315-975	Anti-Diarrheal	Loperamide HCl	FRED'S, INC.	ANDA	Current
55315-975	Anti-Diarrheal	Loperamide HCl	FRED'S, INC.	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
55319-375	Anti-Diarrheal	Loperamide HCl	Family Dollar Services Inc	ANDA	Current
57896-381	Anti-Diarrheal	Loperamide HCl	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-381	Anti-Diarrheal	Loperamide HCl	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-381	Anti-Diarrheal	Loperamide HCl	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-381	Anti-Diarrheal	Loperamide HCl	Geri-Care Pharmaceutical Corp	ANDA	Current
57896-381	Anti-Diarrheal	Loperamide HCl	Geri-Care Pharmaceutical Corp	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-559	Anti Diarrheal	Loperamide HCl	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63940-375	Anti Diarrheal	Loperamide HCl	Harmon Store Inc.	ANDA	Current
63940-375	Anti Diarrheal	Loperamide HCl	Harmon Store Inc.	ANDA	Current
63940-375	Anti Diarrheal	Loperamide HCl	Harmon Store Inc.	ANDA	Current
63941-375	Anti-Diarrheal	Loperamide HCl	Valu Merchandisers Company	ANDA	Current
63941-375	Anti-Diarrheal	Loperamide HCl	Valu Merchandisers Company	ANDA	Current
63941-375	Anti-Diarrheal	Loperamide HCl	Valu Merchandisers Company	ANDA	Current
63941-375	Anti-Diarrheal	Loperamide HCl	Valu Merchandisers Company	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-105	Anti-Diarrheal	Loperamide HCl	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
66424-735	ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets	Loperamide HCL	SDA Laboratories, Inc.	ANDA	Current
66424-735	ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets	Loperamide HCL	SDA Laboratories, Inc.	ANDA	Current
66424-735	ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets	Loperamide HCL	SDA Laboratories, Inc.	ANDA	Current
66424-735	ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets	Loperamide HCL	SDA Laboratories, Inc.	ANDA	Current
67091-335	Anti-Diarrheal	Loperamide HCl	WinCo Foods, LLC	ANDA	Current
67091-335	Anti-Diarrheal	Loperamide HCl	WinCo Foods, LLC	ANDA	Current
67091-335	Anti-Diarrheal	Loperamide HCl	WinCo Foods, LLC	ANDA	Current
67091-335	Anti-Diarrheal	Loperamide HCl	WinCo Foods, LLC	ANDA	Current
67091-335	Anti-Diarrheal	Loperamide HCl	WinCo Foods, LLC	ANDA	Current
67091-405	Anti Diarrheal	Loperamide HCL	WinCo Foods	ANDA	Current
68016-301	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68016-301	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68016-301	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68016-301	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68016-638	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68016-638	Anti-diarrheal	Loperamide HCl	Chain Drug Consortium	ANDA	Current
68196-975	anti-diarrheal	Loperamide HCl	Sam's West Inc	ANDA	Current
68196-975	anti-diarrheal	Loperamide HCl	Sam's West Inc	ANDA	Current
68196-975	anti-diarrheal	Loperamide HCl	Sam's West Inc	ANDA	Current