Alprazolam
- Product NDC
- 65162-813
- 11-digit product format
- 651620813
- Labeler code
- 65162
- Product ID
- 65162-813_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078387
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- ALPRAZOLAM
- Active strength
- 3 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALPRAZOLAM | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YU55MQ3IZY |
| Rxcui | 433798, 433799, 433800, 433801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-813-03 | Alprazolam | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 15 |
| 65162-813-06 | Alprazolam | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 15 |
| 65162-813-50 | Alprazolam | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC] | 6 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS, LLC] | 6 | |
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ALPRAZOLAM TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-813 | ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 15 | Current NDC, Legacy NDC, 3 package rows | 20240322_259387c1-e374-4bc2-9510-5f7f2c60d1a5.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 |
|---|
| 65162-813-03 | 65162081303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-03) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 65162-813-06 | 65162081306 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-06) | 2009-12-03 | 0000-00-00 | No | No | Current |
| 65162-813-50 | 65162081350 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-813-50) | 2009-12-03 | 0000-00-00 | No | No | Current |