Home Applications 075232 Application 075232
Type ANDA
Sponsor L PERRIGO CO 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 A075232-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06
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 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 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 · 25 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 123 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0224 Good Sense anti diarrheal Loperamide Hydrochloride L. Perrigo Company ANDA Current 0113-0224 Good Sense anti diarrheal Loperamide Hydrochloride L. Perrigo Company ANDA Current 0113-0224 Good Sense anti diarrheal Loperamide Hydrochloride L. Perrigo Company ANDA Current 0113-2224 anti diarrheal Loperamide HCl L. Perrigo Company ANDA Current 0113-2224 anti diarrheal Loperamide HCl L. Perrigo Company ANDA Current 0113-2224 anti diarrheal Loperamide HCl L. Perrigo Company ANDA Current 0113-6004 injoy diarrhea relief Loperamide HCl L. Perrigo Company ANDA Current 0113-7224 loperamide hydrochloride Loperamide HCl L. Perrigo Company ANDA Current 0113-7224 Basic Care loperamide hydrochloride Loperamide HCl L. Perrigo Company ANDA Current 0113-7224 Basic Care loperamide hydrochloride Loperamide HCl L. Perrigo Company ANDA Current 0363-1010 anti diarrheal Loperamide HCl Walgreen Company ANDA Current 0363-1010 anti diarrheal Loperamide HCl Walgreen Company ANDA Current 0904-7725 anti diarrheal Loperamide Hydrochloride Major Pharmaceuticals ANDA Current 0904-7725 anti diarrheal Loperamide Hydrochloride Major Pharmaceuticals ANDA Current 0904-7725 anti diarrheal Loperamide Hydrochloride Major Pharmaceuticals ANDA Current 10202-224 7 Select Anti Diarrheal Loperamide HCl 7-Eleven ANDA Current 10202-224 7 Select Anti Diarrheal Loperamide HCl 7-Eleven ANDA Current 11673-224 Up and Up anti diarrheal Loperamide Hydrochloride Target Corporation ANDA Current 11673-224 Up and Up anti diarrheal Loperamide Hydrochloride Target Corporation ANDA Current 11673-224 Up and Up anti diarrheal Loperamide Hydrochloride Target Corporation ANDA Current 11673-224 Up and Up anti diarrheal Loperamide Hydrochloride Target Corporation ANDA Current 24385-386 good neighbor pharmacy anti diarrheal Loperamide HCl Amerisource Bergen ANDA Current 24385-386 good neighbor pharmacy anti diarrheal Loperamide HCl Amerisource Bergen ANDA Current 24385-554 good neighbor pharmacy anti diarrheal Loperamide Hydrochloride Amerisource Bergen ANDA Current 24385-554 good neighbor pharmacy anti diarrheal Loperamide Hydrochloride Amerisource Bergen ANDA Current 24385-554 good neighbor pharmacy anti diarrheal Loperamide Hydrochloride Amerisource Bergen ANDA Current 24385-554 good neighbor pharmacy anti diarrheal Loperamide Hydrochloride Amerisource Bergen ANDA Current 30142-998 Anti Diarrheal Loperamide Hydrochloride Kroger Company ANDA Current 30142-998 Anti Diarrheal Loperamide Hydrochloride Kroger Company ANDA Current 30142-998 Anti Diarrheal Loperamide Hydrochloride Kroger Company ANDA Current 36800-224 topcare anti diarrheal Loperamide Hydrochloride Topco Associates LLC ANDA Current 36800-224 topcare anti diarrheal Loperamide Hydrochloride Topco Associates LLC ANDA Current 36800-224 topcare anti diarrheal Loperamide Hydrochloride Topco Associates LLC ANDA Current 37012-224 anti diarrheal Loperamide HCl Shopko Stores Operating Co., LLC ANDA Current 37012-224 anti diarrheal Loperamide HCl Shopko Stores Operating Co., LLC ANDA Current 37205-370 Leader Anti Diarrheal Loperamide HCl Cardinal Health ANDA Current 37808-552 Anti Diarrheal Loperamide HCl H E B ANDA Current 37808-552 Anti Diarrheal Loperamide HCl H E B ANDA Current 37808-552 Anti Diarrheal Loperamide HCl H E B ANDA Current 41190-224 ShopRite Anti Diarrheal Loperamide HCl Wakefern Food Corporation ANDA Current 41190-224 ShopRite Anti Diarrheal Loperamide HCl Wakefern Food Corporation ANDA Current 41250-224 anti diarrheal Loperamide Hydrochloride Meijer Distribution Inc ANDA Current 41250-224 anti diarrheal Loperamide Hydrochloride Meijer Distribution Inc ANDA Current 41250-224 anti diarrheal Loperamide Hydrochloride Meijer Distribution Inc ANDA Current 41250-224 anti diarrheal Loperamide Hydrochloride Meijer Distribution Inc ANDA Current 41520-813 CareOne Diarrhea Control Loperamide HCl American Sales Company ANDA Current 41520-813 CareOne Diarrhea Control Loperamide HCl American Sales Company ANDA Current 41520-813 CareOne Diarrhea Control Loperamide HCl American Sales Company ANDA Current 42507-224 anti diarrheal Loperamide Hydrochloride HyVee Inc ANDA Current 49035-224 Equate anti diarrheal Loperamide Hydrochloride Wal-Mart Stores Inc ANDA Current 49035-224 Equate anti diarrheal Loperamide Hydrochloride Wal-Mart Stores Inc ANDA Current 49348-529 sunmark anti diarrheal Loperamide Hydrochloride McKesson ANDA Current 49348-529 sunmark anti diarrheal Loperamide Hydrochloride McKesson ANDA Current 49348-529 sunmark anti diarrheal Loperamide Hydrochloride Strategic Sourcing Services LLC ANDA Current 49348-529 sunmark anti diarrheal Loperamide Hydrochloride Strategic Sourcing Services LLC ANDA Current 49738-700 smart sense anti diarrheal Loperamide Hydrochloride Kmart Corporation ANDA Current 49738-700 smart sense anti diarrheal Loperamide Hydrochloride Kmart Corporation ANDA Current 49781-128 leader anti-diarrheal Loperamide HCl Cardinal Health ANDA Current 49781-128 leader anti-diarrheal Loperamide HCl Cardinal Health ANDA Current 49781-128 leader anti-diarrheal Loperamide HCl Cardinal Health ANDA Current 50580-317 Imodium Loperamide hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-317 Imodium Loperamide hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-317 Imodium Loperamide hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-317 Imodium Loperamide hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 53117-224 fad first aid direct anti-diarrheal Loperamide HCl First Aid Direct ANDA Current 53117-224 fad first aid direct anti-diarrheal Loperamide HCl First Aid Direct ANDA Current 55316-224 healthy accents anti diarrheal Loperamide Hydrochloride DZA Brands LLC ANDA Current 55319-224 family wellness anti diarrheal Loperamide HCl Family Dollar Services Inc ANDA Current 55319-224 family wellness anti diarrheal Loperamide HCl Family Dollar Services Inc ANDA Current 55319-224 family wellness anti diarrheal Loperamide HCl Family Dollar Services Inc ANDA Current 55319-224 family wellness anti diarrheal Loperamide HCl Family Dollar Services Inc ANDA Current 55910-224 dg health anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 55910-224 dg health anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 55910-224 dg health anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 55910-224 dg health anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 55910-700 rexall anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 55910-700 rexall anti diarrheal Loperamide Hydrochloride Dolgencorp, LLC ANDA Current 56062-224 anti diarrheal Loperamide Hydrochloride Publix Super Markets Inc ANDA Current 56062-224 anti diarrheal Loperamide Hydrochloride Publix Super Markets Inc ANDA Current 59779-700 anti diarrheal Loperamide Hydrochloride CVS Pharmacy ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42961 ORIG 2001-12-28 30806 ORIG 2000-01-06 18394 ORIG 2000-01-06