Zolpidem Tartrate
- Product NDC
- 71610-564
- Requested package NDC
- 71610-564-30
- 11-digit product format
- 716100564
- Labeler code
- 71610
- Product ID
- 71610-564_64f6704f-5cba-4299-b85f-d95bb633f29d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078148
- Marketing category
- ANDA
- Marketing start
- 2010-12-03
- Marketing end
- 0000-00-00
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 13 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
- 2022-12-31
- 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 package | package | 71610-564 | 71610-564-30 | D | Discontinued by firm | 2026-08-17 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71610-564 | 71610-564-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71610-564 | 71610-564-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078148-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | ||
| A078148-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 |
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 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078148-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078148-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078148-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078148-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078148-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078148-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078148-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078148-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078148-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078148-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078148-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078148-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078148-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078148-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078148-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078148-002 | AB | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | A078148-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078148-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078148-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078148-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078148-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078148-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078148-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A078148-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A078148-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A078148-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078148-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078148-002 | AB | 1 | cb3db0bc1861… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-564-30 | EA - Each | 71610-564 | 2a58f963-7bbf-4ebe-97a5-62f308549f87 | 1 | 2021-08-05 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71610-564-30 | 71610056430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-564-30) | 2021-06-02 | 0000-00-00 | No | No | Current |