NDC codes

FDA NDC Directory
Product NDC (as listed)68788-6875Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-6875Add 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
68788-6875-3687886875036878868750330 TABLET, FILM COATED in 1 BOTTLE (68788-6875-3)Marketed from Jan 23, 2017
68788-6875-6687886875066878868750660 TABLET, FILM COATED in 1 BOTTLE (68788-6875-6)Marketed from Jan 23, 2017
68788-6875-9687886875096878868750990 TABLET, FILM COATED in 1 BOTTLE (68788-6875-9)Marketed from Jan 23, 2017

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 — 1 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 203687
Marketing start
Listing expires
Other FDA classes
5-alpha Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68788-6875_a563a09c-a5e6-4069-a9e9-1f25b1372fa9SPL ID a563a09c-a5e6-4069-a9e9-1f25b1372fa9SPL set ID 74b90430-8ce1-470c-939c-685ca9dfd74fRxCUI 200172UNII 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

N468788687503 followed by a unit qualifier and the quantity

Package 68788-6875-03. 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 indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women. • Finasteride is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1) . • Finasteride tablets are not indicated for use in women ( 1 , 4 , 5.1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-6875

What is NDC 68788-6875?
68788-6875 is the product NDC for Finasteride, Finasteride 1 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 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 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 203687

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

FDA NDC Directory listings under ANDA 203687
ProductStrengthForm · routeLabelerProduct NDC
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralBurel Pharmaceuticals, LLC35573-400
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-061
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-927
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3993
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4808
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4687
FinasterideFinasteride 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-151

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