NDC codes

FDA NDC Directory
Product NDC (as listed)50268-314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0314Add 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
50268-314-15502680314155026803141550 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11)Marketed from Jan 23, 2019

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
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090061
Marketing start
Listing expires
Other FDA classes
5-alpha Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50268-314_47e3617a-bbfd-d911-e063-6294a90ace48SPL ID 47e3617a-bbfd-d911-e063-6294a90ace48SPL set ID 800fa54c-c008-ba1e-e053-2a91aa0a2b07RxCUI 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

N450268031415 followed by a unit qualifier and the quantity

Package 50268-0314-15. 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)

Finasteride tablets USP, 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 tablets USP 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 USP is not approved for the prevention of prostate cancer (1.3) . 1.1 Monotherapy Finasteride tablets …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-314

What is NDC 50268-314?
50268-314 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?
AvPAK, NDC labeler code 50268. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-468770518-4687-00
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralCoupler LLC67046-105867046-1058-03
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-263955154-2639-00
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-874968788-8749-0168788-8749-0368788-8749-06+1 more
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-843368788-8433-0168788-8433-0368788-8433-06+1 more
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralDirect_Rx72189-54272189-0542-3072189-0542-90
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-837768788-8377-0168788-8377-0368788-8377-06+1 more
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-361670518-3616-0170518-3616-0370518-3616-04+1 more
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-360070518-3600-0170518-3600-0370518-3600-04
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-71447335-0714-0847335-0714-1847335-0714-81+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
ProductStrengthForm · routeLabelerProduct NDC
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-8377
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-525
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6830
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1936
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2639
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8083
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3182
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-541
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralExelan Pharmaceuticals Inc.76282-412
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7228
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-515

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