Application 022196
- Type
- NDA
- Sponsor
- AYTU
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLPIMIST | ZOLPIDEM TARTRATE | SPRAY, METERED;ORAL | 5MG/SPRAY | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022196-001 | ZOLPIMIST | ZOLPIDEM TARTRATE | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product |
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 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD | 2008-12-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022196-001 | ZOLPIMIST | 5MG/SPRAY | SPRAY, METERED / ORAL | RLD, RS | 2008-12-19 | e64feba35796… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022196-001 | 8236285 | 2032-08-07 | U-70 | Drug substance, Drug product | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 413b6f65-101e-e2cf-0802-711d080b851b | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | REMEDYREPACK INC. | 2abdcf77-d3ed-42bc-acd9-545aab75d567 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | St. Mary's Medical Park Pharmacy | 507225e2-80ba-18c4-e054-00144ff88e88 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | TORRENT PHARMACEUTICALS LIMITED | 9025a6f7-5501-4aba-875e-222ef39848c0 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 90201886-86a5-4c59-a4f1-98270d620731 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | bf99cd5c-9671-45a6-bda9-3dfc8252efdd | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Torrent Pharmaceuticals Limited | 1584bad1-7bf4-4805-bdd9-7eb0fac92721 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | St. Mary's Medical Park Pharmacy | 89cfb1d5-437c-4c13-8f9b-b6851ffba87b | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | REMEDYREPACK INC. | cf3dcbde-b92a-4802-98e4-14f00abdf99e | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | St. Mary's Medical Park Pharmacy | 21767f56-ce92-2b8c-e063-6394a90a8b76 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Umedica Laboratories USA Inc. | b49f6c18-e155-4728-a79a-9354e8c3c8f4 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Golden State Medical Supply, Inc. | 2b5cf535-ccdc-ecd7-e063-6394a90a726e | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | REMEDYREPACK INC. | 0f8488f3-851d-4111-af23-60f420aad0d6 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | The ACME Laboratories Ltd. | 5679ed64-8424-4e63-a3c9-91d80fff2ca6 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals,Inc. | bca751bb-5161-5a95-e053-2a95a90aa2dd | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 2556c804-7a5e-4dbd-aeef-a3ba3a247c39 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | f67ef513-1b2c-42fe-bf33-4c7e9db191a3 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Calvin Scott & Co., Inc. | 7da75d2b-905c-4fdf-bc53-1358c6477755 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | A-S Medication Solutions | 59cc61da-838e-4add-b2d6-42b2b283a000 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Direct_Rx | 907c7b18-2638-512c-e053-2995a90ae6fd | 2026-01-08 | Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58407-510 | ZolpiMIST | Zolpidem Tartrate | Magna Pharmaceuticals, Inc. | NDA | Current |
| 58407-510 | ZolpiMIST | Zolpidem Tartrate | Magna Pharmaceuticals, Inc. | NDA | Current |
| 69654-510 | ZOLPIMIST | zolpidem tartrate | Aytu BioScience, Inc. | NDA | Current |
| 69654-510 | ZOLPIMIST | zolpidem tartrate | Aytu BioScience, Inc. | NDA | Current |
| 69654-510 | ZOLPIMIST | zolpidem tartrate | Aytu BioPharma, Inc. | NDA | Current |
| 69654-510 | ZOLPIMIST | zolpidem tartrate | Aytu BioPharma, Inc. | NDA | Current |