Zolpidem Tartrate
- Product NDC
- 76420-416
- Requested package NDC
- 76420-416-90
- 11-digit product format
- 764200416
- Labeler code
- 76420
- Product ID
- 76420-416_3aa8cb56-eaef-625f-e063-6394a90a52ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA078413
- Marketing category
- ANDA
- Marketing start
- 2007-05-04
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolpidem Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZOLPIDEM TARTRATE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WY6W63843K | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9922ce14-b418-4235-9c59-d674a8e70210 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 75543837-e611-4401-8337-81e7d5cb9b04 | Product name | 1 | 20231011 |
| f40c5cae-52e4-45d3-95e3-8ba7f79e50e4 | Product name | 3 | 20201208 |
| 70793b8c-c4d9-ddb4-5f8a-4308eb0087a2 | Product name | 4 | 20171109 |
| 3970acdc-9e18-4f3d-165e-245802aafc57 | Product name | 2 | 20160829 |
| 438b1497-0992-6caa-062f-3853a7f9e4b1 | Product name | 1 | 20140508 |
| 813c8976-a1f1-3a35-1a71-1557bfb59446 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76420-416-00 | Zolpidem Tartrate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 1 | |
| 76420-416-01 | Zolpidem Tartrate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 76420-416-05 | Zolpidem Tartrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 1 | |
| 76420-416-30 | Zolpidem Tartrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 76420-416-60 | Zolpidem Tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 | |
| 76420-416-90 | Zolpidem Tartrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1 |
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 76420-416-90 76420-416 76420041690 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854873 | zolpidem tartrate 10 MG Oral Tablet | PSN | 9922ce14-b418-4235-9c59-d674a8e70210 | 1 |
| 854876 | zolpidem tartrate 5 MG Oral Tablet | PSN | 9922ce14-b418-4235-9c59-d674a8e70210 | 1 |
| 854873 | zolpidem tartrate 10 MG Oral Tablet | SCD | 9922ce14-b418-4235-9c59-d674a8e70210 | 1 |
| 854876 | zolpidem tartrate 5 MG Oral Tablet | SCD | 9922ce14-b418-4235-9c59-d674a8e70210 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 76420-416-90 | 76420041690 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-416-90) | 2025-07-24 | No | No | Current |