Zolpidem Tartrate
- Product NDC
- 0228-3481
- 11-digit product format
- 002283481
- Labeler code
- 0228
- Product ID
- 0228-3481_018077ff-d4f5-4be3-9a8e-3061ab1fe026
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078179
- Marketing category
- ANDA
- Marketing start
- 2010-10-14
- Marketing end
- 2019-12-31
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 6 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 | 0228-3481 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0228-3481 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 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 | 0228-3481-11 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078179-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | ||
| A078179-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 |
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 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-06-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-10-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078179-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2011-06-06 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078179-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2010-10-13 | 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 | A078179-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078179-002 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078179-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078179-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078179-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078179-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078179-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078179-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078179-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078179-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078179-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078179-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078179-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078179-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078179-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078179-002 | AB | 1 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| 75543837-e611-4401-8337-81e7d5cb9b04 | Product name | 1 | 20231011 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| f40c5cae-52e4-45d3-95e3-8ba7f79e50e4 | Product name | 3 | 20201208 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 70793b8c-c4d9-ddb4-5f8a-4308eb0087a2 | Product name | 4 | 20171109 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 3970acdc-9e18-4f3d-165e-245802aafc57 | Product name | 2 | 20160829 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 438b1497-0992-6caa-062f-3853a7f9e4b1 | Product name | 1 | 20140508 |
| 813c8976-a1f1-3a35-1a71-1557bfb59446 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0228-3481-11 | EA - Each | 0228-3481 | 0d28a163-3971-41a6-859c-38f50e53eca5 | 1 | 2012-07-24 |
| 0228-3481-50 | EA - Each | 0228-3481 | 9c62dc18-aae0-495a-ae02-11572db56323 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854894 | zolpidem tartrate 6.25 MG Extended Release Oral Tablet | PSN | 4735f5c3-3038-4e1b-9fe4-47158550f14b | 1 |
| 854894 | zolpidem tartrate 6.25 MG Extended Release Oral Tablet | SCD | 4735f5c3-3038-4e1b-9fe4-47158550f14b | 1 |