Prescription drug · ANDA
Alfuzosin Hydrochloride NDC 71335-2578
Alfuzosin hydrochloride 10 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2578-1 | 71335257801 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-1)Marketed from Feb 6, 2025 | |
| 71335-2578-2 | 71335257802 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-2)Marketed from Feb 6, 2025 | |
| 71335-2578-3 | 71335257803 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3)Marketed from Feb 6, 2025 | |
| 71335-2578-4 | 71335257804 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-4)Marketed from Feb 6, 2025 | |
| 71335-2578-5 | 71335257805 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-5)Marketed from Feb 6, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Bryant Ranch Prepack
- 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 71335-2578_7ce6f1ee-cf32-445d-a682-b01823587446SPL ID 7ce6f1ee-cf32-445d-a682-b01823587446SPL set ID 37e89394-af6e-4700-bfa8-2effba1a286bRxCUI 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
N471335257801followed by a unit qualifier and the quantityPackage 71335-2578-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | Northwind Health Company, LLC | 51655-087 |
| 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 |