Home Applications 076497 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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 84e616aacf4f…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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