NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8433Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8433Add 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
68788-8433-16878884330168788843301100 TABLET, FILM COATED in 1 BOTTLE (68788-8433-1)Marketed from Apr 24, 2024
68788-8433-3687888433036878884330330 TABLET, FILM COATED in 1 BOTTLE (68788-8433-3)Marketed from Apr 24, 2024
68788-8433-6687888433066878884330660 TABLET, FILM COATED in 1 BOTTLE (68788-8433-6)Marketed from Apr 24, 2024
68788-8433-9687888433096878884330990 TABLET, FILM COATED in 1 BOTTLE (68788-8433-9)Marketed from Apr 24, 2024

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204304
Marketing start
Listing expires
Other FDA classes
5-alpha Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68788-8433_5d4b1d8d-6e91-42aa-bc00-454a8cf4d30aSPL ID 5d4b1d8d-6e91-42aa-bc00-454a8cf4d30aSPL set ID 33295dce-1e81-4187-bce1-d9b332ea062eRxCUI 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

N468788843301 followed by a unit qualifier and the quantity

Package 68788-8433-01. 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 .

Indications (excerpt from the label)

Finasteride tablets, are 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 are not approved for the prevention of prostate cancer ( 1.3…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8433

What is NDC 68788-8433?
68788-8433 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Preferred 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-06182009-0061-05

All 69 Finasteride NDCs

Other NDCs under ANDA 204304

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

FDA NDC Directory listings under ANDA 204304
ProductStrengthForm · routeLabelerProduct NDC
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-767
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralDirect_Rx72189-542
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7086
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4697
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2999
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-288
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-520
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1898
FinasterideFinasteride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3600

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