Alprazolam
- Product NDC
- 71335-1129
- 11-digit product format
- 713351129
- Labeler code
- 71335
- Product ID
- 71335-1129_a6043a23-294d-4ed2-8f21-6efa8658f743
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078056
- Marketing category
- ANDA
- Marketing start
- 2007-03-12
- Substance
- ALPRAZOLAM
- Active strength
- .5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Brand name suffix
- Extended Release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALPRAZOLAM | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YU55MQ3IZY |
| Rxcui | 433798 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1129-1 | 2024-05-17 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-2 | 2024-05-17 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-3 | 2024-05-17 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-4 | 2024-05-17 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
| 71335-1129-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6184-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use ALPRAZOLAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM EXTENDED-RELEASE TABLETS. ALPRAZOLAM extended-release tablets, for oral use, CIV Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1129-1 | AlprazolamExtended Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 101 |
| 71335-1129-2 | AlprazolamExtended Release | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 101 |
| 71335-1129-3 | AlprazolamExtended Release | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 101 |
| 71335-1129-4 | AlprazolamExtended Release | 45 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 45 | | 101 |
| 71335-1129-5 | AlprazolamExtended Release | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1129 | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 5 package rows | 20240518_29477df1-68aa-44b3-bf9e-80ecff6ce879.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1129-1 | 71335112901 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1129-1) | 2019-02-26 | 0000-00-00 | No | No | Current |
| 71335-1129-2 | 71335112902 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1129-2) | 2019-02-26 | 0000-00-00 | No | No | Current |
| 71335-1129-3 | 71335112903 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1129-3) | 2019-02-26 | 0000-00-00 | No | No | Current |
| 71335-1129-4 | 71335112904 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1129-4) | 2024-05-17 | 0000-00-00 | No | No | Current |
| 71335-1129-5 | 71335112905 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1129-5) | 2024-05-17 | | No | No | Current |