Zolpidem Tartrate
- Product NDC
- 68788-7773
- 11-digit product format
- 687887773
- Labeler code
- 68788
- Product ID
- 68788-7773_b595ec2f-d67b-4b0f-93c9-da5d9e5cab0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA204170
- Marketing category
- ANDA
- Marketing start
- 2020-08-24
- 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
- 2021-12-31
- 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 | 68788-7773 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 68788-7773 | 68788-7773-2 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 68788-7773 | 68788-7773-3 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 68788-7773 | 68788-7773-6 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 68788-7773 | 68788-7773-9 | D | Discontinued by firm | 2026-08-07 |
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 | 68788-7773-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7773-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7773-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-7773-3 | 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 | 68788-7773-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7773-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7773-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-7773-3 | 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 | 68788-7773-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7773-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7773-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-7773-3 | 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 | 68788-7773-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7773-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7773-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-7773-3 | 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 | 68788-7773-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7773-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7773-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-7773-3 | 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 | 68788-7773-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7773-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7773-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-7773-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7773-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7773-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7773-9 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-7773-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7773-6 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7773-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7773-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-7773-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7773-6 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7773-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7773-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-7773-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7773-6 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7773-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7773-9 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-7773-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7773-6 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7773-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7773-9 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-7773-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-7773-6 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-7773-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-7773-9 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-7773-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204170-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | |
| A204170-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204170-001 | AB |
| A204170-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204170-001 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204170-002 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-01-24 | 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 | A204170-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204170-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204170-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204170-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204170-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204170-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204170-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204170-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204170-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204170-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204170-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204170-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204170-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204170-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204170-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204170-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204170-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204170-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204170-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204170-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204170-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204170-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204170-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204170-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204170-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204170-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204170-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A204170-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204170-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204170-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204170-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204170-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204170-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204170-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204170-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204170-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204170-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204170-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204170-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204170-002 | 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 | Bryant Ranch Prepack | 90201886-86a5-4c59-a4f1-98270d620731 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 204170 ANDA204170 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 8425be72-2bbe-4090-b00e-610f1a1646b1 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 204170 ANDA204170 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals Inc. | 625fad5b-8817-4773-a2fc-20b662140e6e | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 204170 ANDA204170 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | a1faca42-6e46-4586-97ac-050b724e7d2a | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 204170 ANDA204170 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Sun Pharmaceutical Industries, Inc. | 0c64bc71-2e7f-4b15-a8e1-acb8de04395f | 2023-10-18 | Boxed warning, Warnings, Adverse reactions | 204170 ANDA204170 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | ebd6c66b-b230-48d7-b38f-d610b6cb2b6c | 2019-03-02 | Warnings, Adverse reactions | 204170 ANDA204170 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7773-2 | 68788777302 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7773-2) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 68788-7773-3 | 68788777303 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7773-3) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 68788-7773-6 | 68788777306 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7773-6) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 68788-7773-9 | 68788777309 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7773-9) | 2020-08-24 | 0000-00-00 | No | No | Current |