Application 075232
- Type
- ANDA
- Sponsor
- L PERRIGO CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| 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.
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| anti diarrheal | LOPERAMIDE HCL | CVS Pharmacy | 68467222-c8b4-4029-a180-59a57d0090d3 | 2022-10-24 | Warnings | 075232 ANDA075232 |
| leader anti diarrheal | LOPERAMIDE HCL | Cardinal Health 110, LLC. dba Leader | 6761d752-f529-41a7-9b33-73c79481d481 | 2021-10-07 | Warnings | 075232 ANDA075232 |
| basic care loperamide hydrochloride | LOPERAMIDE HCL | Amazon.com Services LLC | 732edad8-9a3f-4ce0-a323-c8bffa4acb5f | 2021-02-17 | Warnings | 075232 ANDA075232 |
| anti diarrheal | LOPERAMIDE HCL | L. Perrigo Company | e5c96703-1487-4943-9b16-fa6a05e6b02e | 2019-12-17 | Warnings | 075232 ANDA075232 0113-2224 |
| Good Sense anti diarrheal | LOPERAMIDE HYDROCHLORIDE | Proficient Rx LP | 345be8d9-4fc9-40a2-a9f3-775d48beb85b | 2019-10-01 | Warnings | 075232 ANDA075232 |
NDC Listings For This Application#
| 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 |