Prescription drug · NDA
Cardura XL (Doxazosin mesylate) NDC 58151-079
Doxazosin mesylate 8 mg/1 · Tablet, Film coated, Extended release · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-079-93 | 5815100799358151007993 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)Marketed from Jan 4, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cardura XLSuffix: XL
- Generic name (nonproprietary)
- doxazosin mesylate
- Active ingredients
- Doxazosin mesylate — 8 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021269
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 58151-079_7fe31b0a-4fb2-427f-83e2-d5b957d6738bSPL ID 7fe31b0a-4fb2-427f-83e2-d5b957d6738bSPL set ID 355bcdce-0481-48ba-8ebd-2009106aaf77RxCUI 636360, 636361, 1242404, 1242408UNII 86P6PQK0MUUPC 0358151078936
- Pharmacologic class
- alpha-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458151007993followed by a unit qualifier and the quantityPackage 58151-0079-93. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
CARDURA ® XL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CARDURA XL is not indicated for the treatment of hypertension. CARDURA XL is an alpha 1 adrenergic antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. ( 1 ) CARDURA XL is not indicated for the treatment of hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58151-079
- What is NDC 58151-079?
- 58151-079 is the product NDC for Cardura XL (doxazosin mesylate), Doxazosin mesylate 8 mg/1 tablet, film coated, extended release, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cardura XL (Doxazosin mesylate).
- What is the active ingredient?
- Doxazosin mesylate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cardura XL?
- 1 other product NDC are listed under this name. See all Cardura XL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cardura XL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cardura XLdoxazosin mesylate | Doxazosin mesylate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-078 | 58151-0078-93 |
Other NDCs under NDA 021269
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cardura XLdoxazosin mesylate | Doxazosin mesylate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-078 |