Prescription drug · NDA
Uroxatral (Alfuzosin hcl) NDC 59212-200
Alfuzosin hydrochloride 10 mg/1 · Tablet, Extended release · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-200-10 | 5921202001059212020010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)Marketed from Jun 3, 2013 | |
| 59212-200-30 | 5921202003059212020030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)Marketed from Jan 18, 2019 |
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)
- Uroxatral
- Generic name (nonproprietary)
- alfuzosin hcl
- Active ingredients
- Alfuzosin hydrochloride — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021287
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 59212-200_ffbc758d-7556-4269-8947-baa7ddb88541SPL ID ffbc758d-7556-4269-8947-baa7ddb88541SPL set ID 9fc7f119-f36b-44cf-945d-940160f3afe3RxCUI 861132, 861134UNII 75046A1XTN
- 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
N459212020010followed by a unit qualifier and the quantityPackage 59212-0200-10. 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)
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. ( 1.1 ) UROXATRAL is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population.
Excerpt only. Read the full label for complete information.
About NDC 59212-200
- What is NDC 59212-200?
- 59212-200 is the product NDC for Uroxatral (alfuzosin hcl), Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Advanz Pharma (US) Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Uroxatral (Alfuzosin HCl).
- What is the active ingredient?
- Alfuzosin hydrochloride.
- Who is the labeler?
- Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Uroxatral?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.