Home Applications 073254 Application 073254
Type ANDA
Sponsor CONTRACT PHARMACAL 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 A073254-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30
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 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073254-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 1993-07-30 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 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE YYBA CORP 568064c9-139d-7233-e063-6294a90a10d4 2026-07-13 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Cardinal Health 107, LLC 74b9893a-18c3-4117-85c2-edab8e7b3b3b 2026-07-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Kesin Pharma Corporation 52e6ecc5-5f3d-9989-e063-6294a90af2dc 2026-06-30 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Sportpharm LLC eb93a17e-7daf-4a9e-94a1-442039a383bd 2026-06-26 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Cardinal Health 107, LLC ca8de42f-8aea-4e35-ab3a-75ecea718f4f 2026-06-04 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Aurobindo Pharma Limited 8e4004be-bf79-4631-9e38-c4e7b6726313 2026-06-03 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 5e1358fc-76de-486a-80dd-7f41e037d9a0 2026-06-01 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack 1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7 2026-05-29 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Preferred Pharmaceuticals Inc. 5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf 2026-05-28 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride LOPERAMIDE HCL Preferred Pharmaceuticals Inc. 0b1f8d41-51b3-4362-8de7-46bca5caff12 2026-05-28 Warnings Name fallback brand name: loperamide hydrochloride Good Sense anti diarrheal LOPERAMIDE HYDROCHLORIDE L. Perrigo Company 9c1d811d-f8d0-418c-aaf7-7b6477deea20 2026-05-20 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE Coupler LLC 518bb0f0-88f2-1c95-e063-6294a90a722f 2026-05-11 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack a2594967-e737-4a23-a710-290ca0e6a272 2026-05-11 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE berkley and jensen anti diarrheal LOPERAMIDE HYDROCHLORIDE BJWC dc29a8e9-f916-49d2-b9a6-d2b4537d7b58 2026-05-08 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE MEDIQUE Diamode LOPERAMIDE HYDROCHLORIDE Sportpharm LLC ac674e5a-94df-4a35-9854-4e66cc17e509 2026-04-24 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE IMO-GEN LABS LLC 1b5f2c7c-baf0-b213-e063-6394a90a25df 2026-04-21 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE Amazon.com Services LLC 04a35525-ae8e-b41e-e063-6294a90ab10e 2026-04-20 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride LOPERAMIDE HCL Meijer Distribution Inc 5f693cf6-dced-425f-b25e-37a9f8ec17d6 2026-04-06 Warnings Name fallback brand name: loperamide hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE DOLGENCORP INC 4db35031-f765-39a6-e063-6394a90a40c9 2026-03-20 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Safecor Health LLC 8b0ac05b-90c1-476b-b001-5801dd21701d 2026-03-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE