Alprazolam
- Product NDC
- 0228-4022
- 11-digit product format
- 002284022
- Labeler code
- 0228
- Product ID
- 0228-4022_38c5b407-25a1-48f5-960e-87ef637b644c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprazolam
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078561
- Marketing category
- ANDA
- Marketing start
- 2010-03-17
- 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
- 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 | 485413, 485414, 485415, 485416 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-4022-11 | Alprazolam | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS ELIZABETH LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-4022 | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ACTAVIS PHARMA, INC.] | 23 | Current NDC, Legacy NDC, 1 package rows | 20230131_5ceed721-2e65-4c81-bd84-f110b1ac9d2e.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 |
|---|
| 0228-4022-11 | 00228402211 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11) | 2010-03-17 | 0000-00-00 | No | No | Current |