Xanax
- Product NDC
- 58151-505
- 11-digit product format
- 581510505
- Labeler code
- 58151
- Product ID
- 58151-505_d8ad22b9-9ba3-4193-a678-23d5563d9511
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alprazolam
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA021434
- Marketing category
- NDA
- Marketing start
- 2024-08-01
- Marketing end
- 2027-02-28
- Substance
- ALPRAZOLAM
- Active strength
- 2 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
- Xanax
- Brand name suffix
- XR
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALPRAZOLAM | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YU55MQ3IZY |
| Rxcui | 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58151-505-91 | XanaxXR | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58151-505 | XANAX XR (ALPRAZOLAM) TABLET, EXTENDED RELEASE [VIATRIS SPECIALTY LLC] | 23 | Current NDC, 1 package rows | 20240806_c8990714-c2f5-4b0c-9f1c-91d77156d962.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58151-505-91 | 58151050591 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-505-91) | 2024-08-01 | 2027-02-28 | No | No | Historical |