Application 021855
- Type
- NDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 1MG | Yes | No |
| 002 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021855-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | |
| N021855-002 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021855-001 | LOPERAMIDE HYDROCHLORIDE | 1MG | CAPSULE / ORAL | RLD | 2005-08-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021855-002 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | RLD, RS | 2005-08-04 | 4b0b4de00fa7… |
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 HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | edae1ea7-7a6a-4971-8a21-c2b508e96f4e | 2022-12-21 | Warnings | 021855 NDA021855 63868-876 |
| WELMATE Anti Diarrheal Loperamide HCl Softgels | LOPERAMIDE HYDROCHLORIDE | YYBA CORP | ae2e15e9-1707-296d-e053-2995a90a1b95 | 2022-11-01 | Warnings | 021855 NDA021855 73581-102 |
| Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | DOLGENCORP, LLC | d1fd9a92-9d96-4921-b789-c1f710ee2351 | 2022-06-03 | Warnings | 021855 NDA021855 |
| Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Rite Aid Corporation | 9cee17ca-bd11-3d40-e053-2995a90ac8fe | 2022-05-24 | Warnings | 021855 NDA021855 |
| Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Strategic Sourcing Services LLC | 1537febf-2816-438b-979a-8c8f16f06de5 | 2022-05-24 | Warnings | 021855 NDA021855 62011-0390 |
| Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | HEB | 3ea49be2-1744-4d14-bc43-09d35fd4b3c7 | 2022-05-19 | Warnings | 021855 NDA021855 |
| Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | AMERISOURCE BERGEN | 1a8f6a42-e74f-4725-b12e-b85c2d015191 | 2022-03-16 | Warnings | 021855 NDA021855 |
| anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | Bionpharma Inc. | 8f1ee652-a4f7-4e5b-874f-46aa641cd43f | 2019-09-09 | Warnings | 021855 NDA021855 69452-176 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59779-520 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CVS Pharmacy | NDA | Current |
| 62011-0158 | Loperamide HCl | LOPERAMIDE HYDROCHLORIDE | McKesson (Health Mart) | NDA | Current |
| 62011-0390 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Strategic Sourcing Services LLC | NDA | Current |
| 62011-0390 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | MCKESSON | NDA | Current |
| 62011-0390 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Strategic Sourcing Services LLC | NDA | Current |
| 63868-748 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-748 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-748 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | NDA | Current |
| 63868-876 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63868-876 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63868-876 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63868-876 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | NDA | Current |
| 63941-520 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | NDA | Current |
| 63941-520 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | NDA | Current |
| 66715-6859 | Lil Drug Store Anti-Diarrheal | Loperamide Hydrochloride | Lil' Drug Store Products, | NDA | Current |
| 66715-6859 | Lil Drug Store Anti-Diarrheal | Loperamide Hydrochloride | Lil' Drug Store Products, Inc. | NDA | Current |
| 68016-058 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Premier Value Alliance LLC | NDA | Current |
| 68016-058 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Premier Value Alliance LLC | NDA | Current |
| 68016-058 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | Premier Value Alliance LLC | NDA | Current |
| 68016-193 | Loperamide HCl | LOPERAMIDE HYDROCHLORIDE | Chain Drug Consortium, LLC | NDA | Current |
| 68016-193 | Loperamide HCl | LOPERAMIDE HYDROCHLORIDE | Chain Drug Consortium, LLC | NDA | Current |
| 69452-176 | anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | Bionpharma Inc. | NDA | Current |
| 69452-266 | anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | Bionpharma Inc. | NDA | Current |
| 69452-266 | anti-diarrheal | LOPERAMIDE HYDROCHLORIDE | Bionpharma Inc. | NDA | Current |
| 69842-061 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CVS Pharmacy, Inc. | NDA | Current |
| 69842-061 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CVS Pharmacy, Inc. | NDA | Current |
| 69842-061 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CVS Pharmacy, Inc. | NDA | Current |
| 70000-0230 | Anti-Diarrheal | Loperamide HCl | Cardinal Health (Leader) 70000 | NDA | Current |
| 70000-0230 | Anti-Diarrheal | Loperamide HCl | Cardinal Health (Leader) 70000 | NDA | Current |
| 70000-0230 | Anti-Diarrheal | Loperamide HCl | Cardinal Health (Leader) 70000 | NDA | Current |
| 70000-0461 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CARDINAL HEALTH | NDA | Current |
| 70000-0461 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CARDINAL HEALTH | NDA | Current |
| 70000-0461 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | CARDINAL HEALTH | NDA | Current |
| 70677-0060 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | MCKESSON | NDA | Current |
| 70677-0060 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES, LLC | NDA | Current |
| 70677-0060 | Anti-Diarrheal | LOPERAMIDE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES, LLC | NDA | Current |
| 73581-102 | WELMATE Anti Diarrheal Loperamide HCl Softgels | LOPERAMIDE HYDROCHLORIDE | YYBA CORP | NDA | Current |
| 73581-102 | WELMATE Anti Diarrheal Loperamide HCl Softgels | LOPERAMIDE HYDROCHLORIDE | YYBA CORP | NDA | Current |
| 73581-102 | WELMATE Anti Diarrheal Loperamide HCl Softgels | LOPERAMIDE HYDROCHLORIDE | YYBA CORP | NDA | Current |
| 80136-851 | ANTI-DIARRHEAL | LOPERAMIDE HYDROCHLORIDE | Northeast Pharma | NDA | Current |
| 80136-851 | ANTI-DIARRHEAL | LOPERAMIDE HYDROCHLORIDE | Northeast Pharma | NDA | Current |