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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076497-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2003-06-10	`cb3db0bc1861…`

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 1 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	Yyba Corp	e3b0a274-8bf9-4d39-a805-97fecca607f6	2026-07-13	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Walgreen Company	31f9b652-e9c9-46ed-a46c-22d30ad11004	2026-07-10	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 0363-0375
Anti-diarrheal	LOPERAMIDE HCL	L.N.K. International, Inc.	e34f5bbc-e43c-a69e-e94d-ebc319518204	2026-06-23	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 50844-375
Anti-Diarrheal	LOPERAMIDE HCL	Discount Drug Mart	91843b17-3c04-482c-a2ba-143193be1595	2026-06-08	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti Diarrheal	LOPERAMIDE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f93a1f1f-2233-4338-9643-1ba48bd000bc	2026-06-03	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Family Dollar Services Inc	769e7182-fa11-4645-8fca-657253f28d9c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	H E B	8f7fea50-70cf-4f9f-a655-30371e5b9d9f	2026-05-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 37808-375
Anti Diarrheal	LOPERAMIDE HCL	Chain Drug Marketing Association, Inc.	dd993f38-a31f-4739-9496-e14186a89053	2026-05-18	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	United Natural Foods, Inc. dba UNFI	f16e07f3-0efb-4451-adbb-e427f9abc7ae	2026-05-18	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 41163-375
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	IMO-GEN LABS LLC	1b5f2c7c-baf0-b213-e063-6394a90a25df	2026-04-21	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Valu Merchandisers Company	70a7f827-f5be-454f-99bf-a7fd1037694e	2026-04-21	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	WinCo Foods, LLC	3990279b-45ee-49cf-9ecf-9ce23731b59a	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Heartland Pharma Co.	e360ba61-556a-4d7f-ab2e-2cb71656d868	2026-04-17	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Grocery Outlet	94279e1f-5d87-40ba-8b4b-56930fdc3e3a	2026-03-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Rite Aid Corporation	c6cc4ba7-0e7a-4dd6-a5cf-b7e16e1a6c75	2026-03-11	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 11822-0375
Anti Diarrheal	LOPERAMIDE HCL	Wal-Mart Stores Inc	b480916e-6383-468d-9e3e-499efea92522	2026-01-19	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 49035-375
ANTI-DIARRHEAL	LOPERAMIDE HCL	Advanced Rx LLC	148cb6b7-28e7-48e9-b464-f42daa90e5da	2025-11-04	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497
Anti-Diarrheal	LOPERAMIDE HCL	Better Living Brands, LLC	8d3ccda2-3886-4ff7-ad10-6440fc4da6bf	2025-10-28	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 21130-375
Anti-Diarrheal	LOPERAMIDE HCL	L.N.K. International, Inc.	c03a9389-8b33-4ade-8ba0-8f303e161a08	2025-10-06	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 50844-259
First Aid Direct Anti-Diarrheal	FIRST AID DIRECT ANTI-DIARRHEAL	Cintas Corp	942b5af1-835e-41dd-bf65-e5b68352aa46	2025-09-29	Warnings	Exact identifier application applno (ANDA): 076497 application number: ANDA076497 ndc (product): 42961-103

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