Application 078964
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078964-001 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078964-001 | AB |
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 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A078964-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078964-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078964-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078964-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078964-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078964-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078964-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078964-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078964-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078964-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078964-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078964-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078964-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078964-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078964-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078964-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078964-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078964-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078964-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078964-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078964-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078964-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078964-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078964-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078964-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078964-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078964-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078964-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078964-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078964-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078964-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078964-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078964-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078964-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078964-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078964-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078964-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078964-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078964-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078964-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A078964-001 | AB | 1 | e64feba35796… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45865-802 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | medsource pharmaceuticals | ANDA | Current |
| 50090-1424 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | A-S Medication Solutions | ANDA | Current |
| 63187-788 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Proficient Rx LP | ANDA | Current |
| 63187-788 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Proficient Rx LP | ANDA | Current |
| 68180-220 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-220 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-220 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-220 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-220 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6864 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6864 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0656 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0656 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0656 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | REMEDYREPACK INC. | ANDA | Current |
| 70518-0656 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | REMEDYREPACK INC. | ANDA | Current |
| 71335-0027 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0027 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0027 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0027 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 71335-0027 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | Bryant Ranch Prepack | ANDA | Current |