Alprazolam
- Product NDC
- 0054-3068
- 11-digit product format
- 000543068
- Labeler code
- 0054
- Product ID
- 0054-3068_d7b8cdff-1337-4ef6-a5fb-654f1d655bfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA074312
- Marketing category
- ANDA
- Marketing start
- 1993-10-31
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YU55MQ3IZY |
| Rxcui | 308050 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3068-44 | Alprazolam | 30 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 30 | | 13 |
| 0054-3068-44 | Alprazolam | 1 in 1 CONTAINER | SOLUTION, CONCENTRATE | 1 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 8 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 8 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ALPRAZOLAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3068 | ALPRAZOLAM SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241115_b945ac6f-796e-41ef-85e9-61007e4a4e9a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-3068-44 | 00054306844 | 1 BOTTLE in 1 CONTAINER (0054-3068-44) / 30 mL in 1 BOTTLE | 1 bottle | 1993-10-31 | 0000-00-00 | No | No | Current |