Alprazolam
- Product NDC
- 49884-213
- 11-digit product format
- 498840213
- Labeler code
- 49884
- Product ID
- 49884-213_38e94d5e-f7e2-4349-94f2-2fba605f5ae6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alprazolam
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA078088
- Marketing category
- ANDA
- Marketing start
- 2009-01-09
- Substance
- ALPRAZOLAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alprazolam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALPRAZOLAM | 1 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 |
|---|
| 49884-213-74 | Alprazolam | 10 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 10 | | 22 |
| 49884-213-74 | Alprazolam | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPRAZOLAM | ACTIVE INGREDIENT | YU55MQ3IZY | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| ALPRAZOLAM | ACTIVE MOIETY | YU55MQ3IZY | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | ALPRAZOLAM (ALPRAZOLAM) TABLET, ORALLY DISINTEGRATING [PAR PHARMACEUTICAL INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-213 | ALPRAZOLAM TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250109_ff1630b4-2044-433c-96bc-0bb4ae8d42a0.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 |
|---|
| 49884-213-74 | 49884021374 | 10 BLISTER PACK in 1 CARTON (49884-213-74) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 10 blister pack | 2009-01-09 | 0000-00-00 | No | No | Current |