Prescription drug · ANDA
Alfuzosin Hydrochloride NDC 51655-087
Alfuzosin hydrochloride 10 mg/1 · Tablet, Film coated, Extended release · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-087-52 | 51655008752 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-087-52)Marketed from Oct 4, 2022 |
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)
- Alfuzosin Hydrochloride
- Generic name (nonproprietary)
- alfuzosin hydrochloride
- Active ingredients
- Alfuzosin hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079060
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 51655-087_46ddcd42-e20f-656c-e063-6294a90a7e5fSPL ID 46ddcd42-e20f-656c-e063-6294a90a7e5fSPL set ID f2a530bd-6a86-251d-e053-2995a90adac4RxCUI 861132UNII 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
N451655008752followed by a unit qualifier and the quantityPackage 51655-0087-52. 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)
Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079060
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 |
|---|---|---|---|---|
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2578 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-249 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-153 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-114 |