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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`e64feba35796…`

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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HCL	Kroger Company	49049c95-b19c-4ff0-a1bd-bc7b4193e875	2025-09-12	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 30142-775
Anti-Diarrheal	LOPERAMIDE HCL	DOLGENCORP, LLC	78814c22-5be2-45ee-b0be-977844746fcc	2025-08-13	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
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
Loperamide HCl	LOPERAMIDE HCL	L.N.K. International, Inc.	547c4197-f573-4b30-9e39-2ab11d343609	2025-07-01	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 50844-735
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
Anti-diarrheal	LOPERAMIDE HCL	BI-MART	a3687b81-1f4d-49d5-a25f-b16560ab83d8	2025-05-01	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
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
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
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
Anti-Diarrheal	LOPERAMIDE HCL	Allegiant Health	aca3742c-2a82-4e91-8aaf-2fce08487e56	2017-11-13	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 177 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
0363-0375	Anti-Diarrheal	Loperamide HCl	Walgreen Company	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-0375	Anti-Diarrheal	Loperamide HCl	Rite Aid Corporation	ANDA	Current
15127-375	Anti-Diarrheal	Loperamide HCl	L&R Distributors, Inc.	ANDA	Current
15127-375	Anti-Diarrheal	Loperamide HCl	L&R Distributors, Inc.	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
21130-375	Anti-Diarrheal	Loperamide HCl	Better Living Brands, LLC	ANDA	Current
30142-775	Anti-Diarrheal	Loperamide HCl	Kroger Company	ANDA	Current
30142-775	Anti-Diarrheal	Loperamide HCl	Kroger Company	ANDA	Current
30142-775	Anti-Diarrheal	Loperamide HCl	Kroger Company	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
33992-0375	Anti-Diarrheal	Loperamide HCl	GREENBRIER INTERNATIONAL, INC.	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
37808-375	Anti-Diarrheal	Loperamide HCl	H E B	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
41163-375	Anti-Diarrheal	Loperamide HCl	SUPERVALU INC.	ANDA	Current
42961-103	First Aid Direct Anti-Diarrheal	First Aid Direct Anti-Diarrheal	Cintas Corp	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-375	Anti Diarrheal	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
50844-259	Anti-Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-259	Anti-Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-259	Anti-Diarrheal	Loperamide HCl Tablets, 2 mg	L.N.K. International, Inc.	ANDA	Current
50844-259	Anti-Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-259	Anti-Diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-375	Anti-diarrheal	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current
50844-735	Loperamide HCl	Loperamide HCl	L.N.K. International, Inc.	ANDA	Current