Application 077824
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 300MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077824-001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | ||
| A077824-002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | AB | 2006-10-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | AB | RS | 2006-10-13 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077824-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2006-10-13 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077824-002 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET / ORAL | 2006-10-13 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077824-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077824-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077824-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077824-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077824-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077824-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077824-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077824-002 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Ranitidine | RANITIDINE | Amneal Pharmaceuticals of New York LLC | b38a3332-5c54-453f-aeb7-070f830955c2 | 2026-05-01 | Adverse reactions | 077824 ANDA077824 53746-253 53746-254 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-8300 | Ranitidine | Ranitidine | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8305 | Ranitidine | Ranitidine | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10544-056 | Ranitidine | Ranitidine | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-516 | Ranitidine | Ranitidine | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-109 | Ranitidine | Ranitidine | Rebel Distributors | ANDA | Current |
| 21695-110 | Ranitidine | Ranitidine | Rebel Distributors | ANDA | Current |
| 33261-099 | Ranitidine | Ranitidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-202 | Ranitidine | Ranitidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33358-316 | Ranitidine | Ranitidine | RxChange Co. | ANDA | Current |
| 35356-670 | Ranitidine | Ranitidine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-809 | Ranitidine | Ranitidine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 42291-724 | Ranitidine | Ranitidine | AvKARE, Inc. | ANDA | Current |
| 42291-724 | Ranitidine | Ranitidine | AvKARE, Inc. | ANDA | Current |
| 42291-724 | Ranitidine | Ranitidine | AvKARE | ANDA | Current |
| 42291-725 | Ranitidine | Ranitidine | AvKARE, Inc. | ANDA | Current |
| 42291-725 | Ranitidine | Ranitidine | AvKARE, Inc. | ANDA | Current |
| 42708-049 | Ranitidine | Ranitidine | QPharma Inc | ANDA | Current |
| 42708-118 | Ranitidine | Ranitidine | QPharma Inc | ANDA | Current |
| 42708-118 | Ranitidine | Ranitidine | QPharma Inc | ANDA | Current |
| 43063-087 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-087 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-844 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-844 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-445 | Ranitidine | Ranitidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-967 | Ranitidine | Ranitidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-967 | Ranitidine | Ranitidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-971 | Ranitidine | Ranitidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-971 | Ranitidine | Ranitidine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-416 | Ranitidine | Ranitidine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-416 | Ranitidine | Ranitidine | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0604 | Ranitidine | Ranitidine | A-S Medication Solutions | ANDA | Current |
| 50090-0605 | Ranitidine | Ranitidine | A-S Medication Solutions | ANDA | Current |
| 50090-0606 | Ranitidine | Ranitidine | A-S Medication Solutions | ANDA | Current |
| 50436-0253 | Ranitidine | Ranitidine | Unit Dose Services | ANDA | Current |
| 50436-0253 | Ranitidine | Ranitidine | Unit Dose Services | ANDA | Current |
| 51655-681 | RANITIDINE | ranitidine hydrochloride | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53217-343 | Ranitidine | Ranitidine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53746-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 53746-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 53746-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53808-0775 | Ranitidine | Ranitidine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55289-319 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-319 | Ranitidine | Ranitidine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 60687-322 | Ranitidine | Ranitidine | American Health Packaging | ANDA | Current |
| 60687-322 | Ranitidine | Ranitidine | American Health Packaging | ANDA | Current |
| 60687-322 | Ranitidine | Ranitidine | American Health Packaging | ANDA | Current |
| 60760-026 | RANITIDINE | RANITIDINE | St Marys Medical Park Pharmacy | ANDA | Current |
| 61919-199 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-199 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 63187-686 | Ranitidine | Ranitidine | Proficient Rx LP | ANDA | Current |
| 63187-686 | Ranitidine | Ranitidine | Proficient Rx LP | ANDA | Current |
| 63629-1671 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-1671 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-6757 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-6757 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7669 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7669 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7669 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8236 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8236 | Ranitidine | Ranitidine | Bryant Ranch Prepack | ANDA | Current |
| 63739-489 | Ranitidine | Ranitidine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-489 | Ranitidine | Ranitidine | McKesson Corporation | ANDA | Current |
| 65162-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-253 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-254 | Ranitidine | Ranitidine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 67046-651 | Ranitidine | Ranitidine | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-652 | Ranitidine | Ranitidine | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-2190 | Ranitidine | Ranitidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2190 | Ranitidine | Ranitidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-1610 | Ranitidine | Ranitidine | Carilion Materials Management | ANDA | Current |