Cardura
- Product NDC
- 58151-079
- 11-digit product format
- 581510079
- Labeler code
- 58151
- Product ID
- 58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxazosin mesylate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA021269
- Marketing category
- NDA
- Marketing start
- 2024-01-04
- Substance
- DOXAZOSIN MESYLATE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardura
- Brand name suffix
- XL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXAZOSIN MESYLATE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 86P6PQK0MU |
| Rxcui | 636360, 636361, 1242404, 1242408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58151-079-93 | CarduraXL | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58151-079 | CARDURA XL (DOXAZOSIN MESYLATE) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC] | 2 | Current NDC, 1 package rows | 20240425_355bcdce-0481-48ba-8ebd-2009106aaf77.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 58151-079-93 | 58151007993 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93) | 2024-01-04 | No | No | Current |