What is NDC 71335-1634?

71335-1634 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Finasteride?

68 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Finasteride NDC 71335-1634 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1634Add 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 NDC	11-digit (billing)	Package
71335-1634-1	7133516340171335163401	100 TABLET, FILM COATED in 1 BOTTLE (71335-1634-1)Marketed from Jun 10, 2020
71335-1634-2	7133516340271335163402	30 TABLET, FILM COATED in 1 BOTTLE (71335-1634-2)Marketed from Jun 10, 2020
71335-1634-3	7133516340371335163403	60 TABLET, FILM COATED in 1 BOTTLE (71335-1634-3)Marketed from Jun 10, 2020
71335-1634-4	7133516340471335163404	90 TABLET, FILM COATED in 1 BOTTLE (71335-1634-4)Marketed from Jun 10, 2020
71335-1634-5	7133516340571335163405	500 TABLET, FILM COATED in 1 BOTTLE (71335-1634-5)Marketed from Jun 10, 2020
71335-1634-6	7133516340671335163406	180 TABLET, FILM COATED in 1 BOTTLE (71335-1634-6)Marketed from Jun 10, 2020

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): Finasteride
Generic name (nonproprietary): finasteride
Active ingredients: Finasteride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090121
Marketing start: May 28, 2010
Listing expires: Dec 31, 2026
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71335-1634_763e08a3-1c25-4229-93c8-3cac476a66a6SPL ID 763e08a3-1c25-4229-93c8-3cac476a66a6SPL set ID 88511bd5-624e-49d6-b80e-1f1d47314fb6RxCUI 310346UNII 57GNO57U7G
Pharmacologic class: 5-alpha Reductase Inhibitor

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

N471335163401 followed by a unit qualifier and the quantity

Package 71335-1634-01. 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

Current FDA label (SPL), effective Sep 18, 2020.

Indications (excerpt from the label)

Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : Finasteride is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy Finasteride tablets 5 mg are indicated for the treatmen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1634

What is NDC 71335-1634?: 71335-1634 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Finasteride.
What is the active ingredient?: Finasteride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Finasteride?: 68 other product NDCs are listed under this name. See all Finasteride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Finasteride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Finasteride	Finasteride 1 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4687	70518-4687-00
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1058	67046-1058-03
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2639	55154-2639-00
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8749	68788-8749-0168788-8749-0368788-8749-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8433	68788-8433-0168788-8433-0368788-8433-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-542	72189-0542-3072189-0542-90
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8377	68788-8377-0168788-8377-0368788-8377-06+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3616	70518-3616-0170518-3616-0370518-3616-04+1 more
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3600	70518-3600-0170518-3600-0370518-3600-04
Finasteride	Finasteride 1 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-714	47335-0714-0847335-0714-1847335-0714-81+2 more

All 69 Finasteride NDCs

Other NDCs under ANDA 090121

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090121
Product	Strength	Form · route	Labeler	Product NDC
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-090
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Atlantic Biologicals Corps	17856-0090
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-265
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3354
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3380
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0433