NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2578Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2578Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71335-2578-17133525780130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-1)Marketed from Feb 6, 2025
71335-2578-27133525780260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-2)Marketed from Feb 6, 2025
71335-2578-37133525780390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3)Marketed from Feb 6, 2025
71335-2578-471335257804120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-4)Marketed from Feb 6, 2025
71335-2578-571335257805100 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
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

N471335257801 followed by a unit qualifier and the quantity

Package 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.

FDA NDC Directory listings under ANDA 079060
ProductStrengthForm · routeLabelerProduct NDC
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-087
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-249
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-153
Alfuzosin HydrochlorideAlfuzosin hydrochloride 10 mg/1Tablet, Film coated, Extended releaseOralRising Pharma Holdings, Inc.57237-114

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