Anti-Diarrheal

Product NDC: 68788-7369
Requested package NDC: 68788-7369-1
11-digit product format: 687887369
Labeler code: 68788
Product ID: 68788-7369_ca641efa-065d-477b-91ef-cab8426e997e
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA076497
Marketing category: ANDA
Marketing start: 2016-08-25
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7369	68788-7369-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7369-2	EA - Each	68788-7369	fbc22281-516e-4ea3-a81e-eaf4d850d81a	1	2024-05-16

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
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
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
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
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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7369-1	68788736901	12 TABLET in 1 BOTTLE (68788-7369-1)	12 tablet	2017-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anti-Diarrheal - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2023-07-25	HUMAN OTC DRUG LABEL	7