What is NDC 76282-412?

76282-412 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals Inc., NDC labeler code 76282. 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 76282-412 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0412Add 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
76282-412-05	7628204120576282041205	500 TABLET, FILM COATED in 1 BOTTLE (76282-412-05)Marketed from May 22, 2015
76282-412-10	7628204121076282041210	1000 TABLET, FILM COATED in 1 BOTTLE (76282-412-10)Marketed from May 22, 2015
76282-412-30	7628204123076282041230	30 TABLET, FILM COATED in 1 BOTTLE (76282-412-30)Marketed from May 22, 2015
76282-412-90	7628204129076282041290	90 TABLET, FILM COATED in 1 BOTTLE (76282-412-90)Marketed from May 22, 2015

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): Finasteride
Generic name (nonproprietary): finasteride
Active ingredients: Finasteride — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Exelan Pharmaceuticals Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090061
Marketing start: May 22, 2015
Listing expires: Dec 31, 2027
Other FDA classes: 5-alpha Reductase Inhibitors (Mechanism)
Identifiers: Product ID 76282-412_6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613SPL ID 6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613SPL set ID 1c1bf77c-f99a-44e4-b71e-ce766afa99b6RxCUI 310346UNII 57GNO57U7GUPC 0376282412900
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

N476282041205 followed by a unit qualifier and the quantity

Package 76282-0412-05. 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 Oct 30, 2020.

Indications (excerpt from the label)

Finasteride tablets 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 acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets 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 tablets is not approved for the prevention of prostate cancer (1.3) . 1.1 Monot…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-412

What is NDC 76282-412?: 76282-412 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 4 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?: Exelan Pharmaceuticals Inc., NDC labeler code 76282. 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 090061

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

FDA NDC Directory listings under ANDA 090061
Product	Strength	Form · route	Labeler	Product NDC
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8377
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-525
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	AvPAK	50268-314
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6830
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1936
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2639
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-8083
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3182
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Legacy Pharmaceutical Packaging, LLC	68645-541
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7228
Finasteride	Finasteride 5 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-515