Prescription drug · NDA
Cardura (Doxazosin) NDC 0049-2512
Doxazosin mesylate 2 mg/1 · Tablet · Oral · ROERIG
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0049-2512-10 | 0004925121000049251210 | 100 TABLET in 1 BOTTLE (0049-2512-10)Marketed from Oct 19, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- doxazosin
- Active ingredients
- Doxazosin mesylate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ROERIGNDC labeler code 0049
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019668
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 0049-2512_a90c5126-2e4c-43ea-a9c0-02c00fe6112fSPL ID a90c5126-2e4c-43ea-a9c0-02c00fe6112fSPL set ID eefc47bc-c10f-49bb-8ef7-5999f798ab39RxCUI 104367, 104368, 104369, 197625, 197626, 197627, 197628, 205544UNII 86P6PQK0MUUPC 0300492512105, 0300492410104, 0300492716107, 0300492614106
- 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
N400049251210followed by a unit qualifier and the quantityPackage 00049-2512-10. 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 is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardi…
Excerpt only. Read the full label for complete information.
About NDC 0049-2512
- What is NDC 0049-2512?
- 0049-2512 is the product NDC for Cardura (doxazosin), Doxazosin mesylate 2 mg/1 tablet, listed with the FDA by ROERIG. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cardura (Doxazosin).
- What is the active ingredient?
- Doxazosin mesylate.
- Who is the labeler?
- ROERIG, NDC labeler code 0049. 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?
- 6 other product NDCs are listed under this name. See all Cardura NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cardura products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carduradoxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Viatris Specialty LLC | 58151-077 | 58151-0077-01 |
| Carduradoxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Viatris Specialty LLC | 58151-076 | 58151-0076-01 |
| Carduradoxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Viatris Specialty LLC | 58151-074 | 58151-0074-01 |
| Carduradoxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Viatris Specialty LLC | 58151-075 | — |
| Carduradoxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | ROERIG | 0049-2716 | 00049-2716-10 |
| Carduradoxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | ROERIG | 0049-2614 | 00049-2614-10 |
Other NDCs under NDA 019668
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 |
|---|---|---|---|---|
| Carduradoxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | ROERIG | 0049-2716 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-927 |
| Doxazosin mesylate | Doxazosin mesylate 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-965 |
| Carduradoxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | ROERIG | 0049-2614 |
| Doxazosin mesylate | Doxazosin mesylate 4 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-1390 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-628 |
| Doxazosin mesylate | Doxazosin mesylate 1 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-1388 |
| Doxazosin mesylate | Doxazosin mesylate 2 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-1389 |
| Doxazosin mesylate | Doxazosin mesylate 8 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-1391 |
| Carduradoxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Viatris Specialty LLC | 58151-075 |
| Doxazosin | Doxazosin mesylate 2 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2420 |
| Carduradoxazosin | Doxazosin mesylate 1 mg/1 | TabletOral | Viatris Specialty LLC | 58151-074 |
| Doxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2440 |
| Carduradoxazosin | Doxazosin mesylate 4 mg/1 | TabletOral | Viatris Specialty LLC | 58151-076 |
| Doxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2480 |
| Carduradoxazosin | Doxazosin mesylate 8 mg/1 | TabletOral | Viatris Specialty LLC | 58151-077 |