Alprazolam
- Product NDC
- 0228-3086
- 11-digit product format
- 002283086
- Labeler code
- 0228
- Product ID
- 0228-3086_e89f9f55-9cd1-4b9d-b0a0-2d0480dd559c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078056
- Marketing category
- ANDA
- Marketing start
- 2007-03-12
- Marketing end
- 2026-07-31
- Substance
- ALPRAZOLAM
- Active strength
- 3 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Brand name suffix
- Extended Release
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 |
|---|
| 0228-3086-06 | AlprazolamExtended Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-3086 | ALPRAZOLAM EXTENDED RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250326_a64496be-bf43-4ba9-a4b1-bd632965c1a0.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 |
|---|
| 0228-3086-06 | 00228308606 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3086-06) | 2007-03-12 | 2026-07-31 | No | No | Current |