Application 076410
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 5MG | No | No |
| 002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076410-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | ||
| A076410-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 |
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 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076410-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076410-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076410-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076410-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076410-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076410-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076410-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076410-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076410-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076410-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076410-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076410-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076410-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076410-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076410-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076410-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076410-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076410-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076410-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076410-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076410-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076410-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076410-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076410-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076410-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076410-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076410-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076410-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076410-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076410-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076410-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076410-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076410-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076410-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076410-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076410-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076410-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076410-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076410-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076410-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076410-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076410-002 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Proficient Rx LP | e534b3ac-1110-465f-8692-6ea585996fb6 | 2019-11-01 | Warnings, Adverse reactions | 076410 ANDA076410 63187-682 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Proficient Rx LP | e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77 | 2019-11-01 | Warnings, Adverse reactions | 076410 ANDA076410 63187-707 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-8046 | Zolpidem Tartrate | Zolpidem Tartrate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8046 | Zolpidem Tartrate | Zolpidem Tartrate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8047 | Zolpidem Tartrate | Zolpidem Tartrate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8047 | Zolpidem Tartrate | Zolpidem Tartrate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 42291-963 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE, Inc. | ANDA | Current |
| 42291-963 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE | ANDA | Current |
| 42291-963 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE | ANDA | Current |
| 42291-964 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE, Inc. | ANDA | Current |
| 42291-964 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE | ANDA | Current |
| 42291-964 | Zolpidem Tartrate | Zolpidem Tartrate | AvKARE | ANDA | Current |
| 61919-803 | AMBIEN | ZOLPIDEM TARTRATE | DIRECT RX | ANDA | Current |
| 61919-803 | AMBIEN | ZOLPIDEM TARTRATE | DIRECT RX | ANDA | Current |
| 61919-948 | AMBIEN | ZOLPIDEM TARTRATE | DIRECT RX | ANDA | Current |
| 61919-948 | AMBIEN | ZOLPIDEM TARTRATE | DIRECT RX | ANDA | Current |
| 63187-682 | Zolpidem Tartrate | Zolpidem Tartrate | Proficient Rx LP | ANDA | Current |
| 63187-682 | Zolpidem Tartrate | Zolpidem Tartrate | Proficient Rx LP | ANDA | Current |
| 63187-707 | Zolpidem Tartrate | Zolpidem Tartrate | Proficient Rx LP | ANDA | Current |
| 63187-707 | Zolpidem Tartrate | Zolpidem Tartrate | Proficient Rx LP | ANDA | Current |
| 67296-1591 | Zolpidem Tartrate | Zolpidem Tartrate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1591 | Zolpidem Tartrate | Zolpidem Tartrate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1591 | Zolpidem Tartrate | Zolpidem Tartrate | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1997 | Zolpidem Tartrate | Zolpidem Tartrate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8970 | Zolpidem Tartrate | Zolpidem Tartrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8971 | Zolpidem Tartrate | Zolpidem Tartrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate | REMEDYREPACK INC. | ANDA | Current |
| 71335-0283 | Zolpidem Tartrate | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0283 | Zolpidem Tartrate | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0283 | Zolpidem Tartrate | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 71610-272 | Zolpidem Tartrate | Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-273 | Zolpidem Tartrate | Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8907 | ORIG | 2007-05-01 |