Zolpidem Tartrate
- Product NDC
- 0615-8225
- 11-digit product format
- 006158225
- Labeler code
- 0615
- Product ID
- 0615-8225_80b88732-7b18-4d2c-a564-7e194a0cfcf4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2018-10-02
- Marketing end
- 2023-08-31
- 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
- 0000-00-00
- 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 | 0615-8225 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0615-8225 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 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 | 0615-8225-39 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078413-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | |
| A078413-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078413-001 | AB |
| A078413-002 | 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 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078413-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-05-04 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A078413-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-05-04 | 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 | A078413-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078413-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078413-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078413-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078413-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078413-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078413-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078413-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078413-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078413-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078413-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078413-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078413-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078413-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078413-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078413-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078413-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078413-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078413-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078413-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078413-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078413-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078413-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078413-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078413-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078413-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078413-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078413-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078413-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078413-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078413-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078413-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078413-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078413-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078413-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078413-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078413-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078413-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078413-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078413-002 | 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 | REMEDYREPACK INC. | cf3dcbde-b92a-4802-98e4-14f00abdf99e | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 2556c804-7a5e-4dbd-aeef-a3ba3a247c39 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | f67ef513-1b2c-42fe-bf33-4c7e9db191a3 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 91511d2f-7066-49a0-90ea-2940d955c85e | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | ef72eb73-d058-4ca3-9013-691aae8426fb | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Asclemed USA, Inc. | 9922ce14-b418-4235-9c59-d674a8e70210 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | PD-Rx Pharmaceuticals, Inc. | 38c838a4-9943-445a-8e80-e823d56eeaa5 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | PD-Rx Pharmaceuticals, Inc. | fda413e7-b1ae-312a-e053-6394a90ab2c6 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals, Inc. | 2b9f696a-b637-4dea-e063-6394a90aeb2e | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | af87df4e-2c97-e23e-e053-2a95a90ab354 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | b2db3979-daa6-6e83-e053-2a95a90a3a2f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx Pharmacy of Tennessee, LLC | c859c752-8a85-2017-e053-2a95a90a771f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 3ba3c29f-3835-4f4f-a39f-56fb42686f5b | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | American Health Packaging | eb850154-4b4b-4d9a-8476-aea1a93fe8d7 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aurobindo Pharma Limited | ea2067bd-1622-4d98-8012-2c09405aa88d | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | NorthStar Rx LLC | 51c9a29c-a285-40d0-bf3a-7e8c944ee39c | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 67cc924a-26e0-431f-9160-32c9d92a46cd | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | acfcfe91-83a0-44ab-95c0-dd98b73ac69a | 2019-01-08 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 7be7f243-e6f8-406f-aed7-be7cedd5630a | 2018-10-15 | Boxed warning, Warnings, Adverse reactions | 078413 ANDA078413 |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 7abb6898-223c-487b-856c-068ac04f7a5c | 2018-09-25 | Warnings, Adverse reactions | 078413 ANDA078413 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0615-8225-39 | 00615822539 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8225-39) | 2018-10-02 | 2023-08-31 | No | No | Current |