Zolpidem Tartrate
- Product NDC
- 43353-026
- 11-digit product format
- 433530026
- Labeler code
- 43353
- Product ID
- 43353-026_6d7a5255-c615-4977-9825-103aff7327c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolpidem tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076578
- Marketing category
- ANDA
- Marketing start
- 2007-04-23
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 43353-026 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 43353-026 | 43353-026-10 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-14 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-15 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-20 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-28 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-45 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-53 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-59 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 43353-026 | 43353-026-60 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-28 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-59 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43353-026-53 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-28 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-59 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43353-026-53 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-28 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-59 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-45 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43353-026-53 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-59 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-45 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43353-026-53 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-28 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-59 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-45 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43353-026-53 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-026-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-026-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-026-28 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43353-026-30 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076578-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | ||
| A076578-002 | 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 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076578-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | 2007-04-23 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076578-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | 2007-04-23 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076578-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076578-002 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | A076578-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076578-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076578-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076578-002 | AB | 1 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-026-14 | EA - Each | 43353-026 | 33f8233d-09a5-4b88-8605-4f43cdfd1d61 | 1 | 2016-09-02 |