Home Applications 074091 Application 074091
Type ANDA
Sponsor OHM LABS 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 A074091-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074091-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1992-12-10 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 1 · 19 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Sportpharm LLC eb93a17e-7daf-4a9e-94a1-442039a383bd 2026-06-26 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Sportpharm LLC ac674e5a-94df-4a35-9854-4e66cc17e509 2026-04-24 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Private Label Distributor LOPERAMIDE HCL 2 MG Unifirst First Aid Corporation 069e7979-a223-4819-b6cf-ea2731bf156b 2025-12-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 47682-200 MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 9cf77219-c98d-487a-a5d3-61ceda6c65f5 2025-10-01 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 71205-316 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Medline Industries, LP 03d68bcf-6413-4fe3-8263-39cc315452d2 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 53329-664 Anti-Diarrheal LOPERAMIDE HCI Lil' Drug Store Products, Inc. eec84fa1-262f-6e77-e053-2995a90a325b 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 29485-9286 Anti-Diarrheal, Circle K LOPERAMIDE HCL TABLET Lil' Drug Store Products, Inc. d3aaad65-f4cd-5eb0-e053-2995a90ade84 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 66715-5529 Anti-Diarrheal, Caseys 4good LOPERAMIDE HCL Lil' Drug Store Products, Inc. 043b0ab4-8fba-37d1-e063-6394a90a4cd4 2024-12-29 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 Lil Drug Store Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Lil' Drug Store Products, Inc. fc23b13e-3005-4f23-aec2-b02a0e48ea11 2024-11-27 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 66715-9859 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Consortium, LLC b070896b-1e22-41d4-a66d-8d3be1699217 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 68016-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Zee Medical Inc 07e1f89c-5bf6-4539-848a-4435e7deb0d2 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 35418-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Ohm Laboratories Inc. c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 51660-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Discount Drug Mart 6bc9771d-09f8-47ce-bbbd-8dd9aae97693 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 53943-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Marc Glassman, Inc. 01efdce1-25ce-45ff-aeb6-f6fba00e59aa 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 68998-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Valu Merchandisers Company 33335063-49a9-4e08-9d77-4cd80e94f021 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 63941-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Fred's Inc. a3bf91ae-22f3-4402-b73c-de026f2d0475 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 55315-123 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Chain Drug Marketing Association Inc. 237b845b-0f02-410d-9750-c95123e6142d 2024-01-11 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 63868-338 Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. 76e32e66-4af5-47a5-83ff-cbba206975d6 2023-03-15 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 67751-162 Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 82e65393-25b7-4114-9c71-5840ee8bad84 2022-05-02 Warnings Exact identifier application applno (ANDA): 074091 application number: ANDA074091 ndc (product): 63187-462
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 62 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0498-1071 Antidiarrheal Relief Loperamide HCl Honeywell Safety Products USA, Inc ANDA Current 0498-1071 Antidiarrheal Relief Loperamide HCl Honeywell Safety Products USA, Inc ANDA Current 0498-1071 Antidiarrheal Relief Loperamide HCl Honeywell Safety Products USA, Inc ANDA Current 0498-1071 Antidiarrheal Relief Loperamide HCl Honeywell Safety Products USA, Inc ANDA Current 15127-338 Loperamide Hydrochloride Loperamide Hydrochloride Select Brand ANDA Current 29485-9286 Anti-Diarrheal Loperamide HCI Mechanical Servants, LLC ANDA Current 35418-123 Loperamide Hydrochloride Loperamide Hydrochloride Zee Medical Inc ANDA Current 35418-123 Loperamide Hydrochloride Loperamide Hydrochloride Zee Medical Inc ANDA Current 37012-123 Loperamide Hydrochloride Loperamide Hydrochloride Shopko Stores Operating Co., LLC ANDA Current 42961-048 Loperamide Hydrochloride Loperamide Hydrochloride Cintas Corporation ANDA Current 46122-169 Loperamide Hydrochloride Loperamide Hydrochloride Amerisource Bergen ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corpor ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 47682-200 MEDIQUE Diamode Loperamide Hydrochloride Unifirst First Aid Corporation ANDA Current 51660-123 Loperamide Hydrochloride Loperamide Hydrochloride Ohm Laboratories Inc. ANDA Current 51660-123 Loperamide Hydrochloride Loperamide Hydrochloride Ohm Laboratories Inc. ANDA Current 52904-443 Stomach Relief Anti Diarrheal LOPERAMIDE HYDROCHLORIDE Select Corporation ANDA Current 53329-664 Loperamide Hydrochloride Loperamide Hydrochloride Medline Industries, Inc. ANDA Current 53329-664 Loperamide Hydrochloride Loperamide Hydrochloride Medline Industries, Inc. ANDA Current 53329-664 Loperamide Hydrochloride Loperamide Hydrochloride Medline Industries, Inc. ANDA Current 53329-664 Loperamide Hydrochloride Loperamide Hydrochloride Medline Industries, LP ANDA Current 53329-664 Loperamide Hydrochloride Loperamide Hydrochloride Medline Industries, LP ANDA Current 53943-123 Loperamide Hydrochloride Loperamide Hydrochloride Discount Drug Mart ANDA Current 53943-123 Loperamide Hydrochloride Loperamide Hydrochloride Discount Drug Mart ANDA Current 55315-123 Loperamide Hydrochloride Loperamide Hydrochloride Fred's Inc. ANDA Current 55315-123 Loperamide Hydrochloride Loperamide Hydrochloride Fred's Inc. ANDA Current 55319-554 Loperamide Hydrochloride Loperamide Hydrochloride Family Dollar Services, Inc. ANDA Current 63187-462 Loperamide Hydrochloride Loperamide Hydrochloride Proficient Rx LP ANDA Current 63187-462 Loperamide Hydrochloride Loperamide Hydrochloride Proficient Rx LP ANDA Current 63187-462 Loperamide Hydrochloride Loperamide Hydrochloride Proficient Rx LP ANDA Current 63187-462 Loperamide Hydrochloride Loperamide Hydrochloride Proficient Rx LP ANDA Current 63868-338 Loperamide Hydrochloride Loperamide Hydrochloride Chain Drug Marketing Association Inc. ANDA Current 63868-338 Loperamide Hydrochloride Loperamide Hydrochloride Chain Drug Marketing Association Inc. ANDA Current 63941-123 Loperamide Hydrochloride Loperamide Hydrochloride Valu Merchandisers Company ANDA Current 63941-123 Loperamide Hydrochloride Loperamide Hydrochloride Valu Merchandisers Company ANDA Current 66715-5529 Anti-Diarrheal, Circle K Loperamide HCl tablet Lil' Drug Store Products, Inc. ANDA Current 66715-5529 Anti-Diarrheal, Circle K Loperamide HCl tablet Lil' Drug Store Products, Inc. ANDA Current 66715-5759 Circle K Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc ANDA Current 66715-5759 Circle K Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc ANDA Current 66715-5759 Circle K Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc ANDA Current 66715-9859 Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc. ANDA Current 66715-9859 Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc. ANDA Current 66715-9859 Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc. ANDA Current 66715-9859 Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride Lil' Drug Store Products, Inc. ANDA Current 67091-239 Loperamide Hydrochloride Loperamide Hydrochloride WinCo Foods, LLC ANDA Current 67091-239 Loperamide Hydrochloride Loperamide Hydrochloride WinCo Foods, LLC ANDA Current 67091-240 Loperamide Hydrochloride Loperamide Hydrochloride WinCo Foods, LLC ANDA Current 67091-240 Loperamide Hydrochloride Loperamide Hydrochloride WinCo Foods, LLC ANDA Current 67751-162 Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. ANDA Current 67751-162 Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. ANDA Current 68016-123 Loperamide Hydrochloride Loperamide Hydrochloride Chain Drug Consortium, LLC ANDA Current 68016-123 Loperamide Hydrochloride Loperamide Hydrochloride Chain Drug Consortium, LLC ANDA Current 68998-123 Loperamide Hydrochloride Loperamide Hydrochloride Marc Glassman, Inc. ANDA Current 68998-123 Loperamide Hydrochloride Loperamide Hydrochloride Marc Glassman, Inc. ANDA Current 71205-316 MEDIQUE Diamode Loperamide Hydrochloride Proficient Rx LP ANDA Current 71205-316 MEDIQUE Diamode Loperamide Hydrochloride Proficient Rx LP ANDA Current