NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3757Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3757Add 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
68071-3757-66807137570660 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3757-6)Marketed from Jan 3, 2025

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)
Dutasteride
Generic name (nonproprietary)
dutasteride
Active ingredients
Dutasteride — .5 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
NuCare Pharmaceuticals, Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209909
Marketing start
Listing expires
Other FDA classes
5-alpha Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68071-3757_2ad2f521-f578-01c4-e063-6394a90ac831SPL ID 2ad2f521-f578-01c4-e063-6394a90ac831SPL set ID 2ad309b1-4497-8b9b-e063-6394a90aa9b4RxCUI 351172UNII O0J6XJN02IUPC 0368071375763
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

N468071375706 followed by a unit qualifier and the quantity

Package 68071-3757-06. 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)

Dutasteride capsules is a 5 alpha-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, and reduce the risk of the need for BPH-related surgery. Dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2) Limitations of Use: Dutasteride capsules is not approved for the prevention of prostate cancer. (1.3) 1.1 Monotherapy Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3757

What is NDC 68071-3757?
68071-3757 is the product NDC for Dutasteride, Dutasteride .5 mg/1 capsule, liquid filled, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dutasteride.
What is the active ingredient?
Dutasteride.
Who is the labeler?
NuCare Pharmaceuticals, Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dutasteride?
20 other product NDCs are listed under this name. See all Dutasteride 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 Dutasteride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DutasterideDutasteride .5 mg/1CapsuleOralBanyan Pharma LLC84091-10084091-0100-90
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralAurobindo Pharma Limited59651-02159651-0021-3059651-0021-90
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralA-S Medication Solutions50090-730550090-7305-0050090-7305-01
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralXLCare Pharmaceuticals, Inc.72865-14072865-0140-3072865-0140-90
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralA-S Medication Solutions50090-785250090-7852-0050090-7852-01
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralNuCare Pharmaceuticals, Inc.68071-385768071-3857-09
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralEpic Pharma, LLC42806-54942806-0549-0942806-0549-30
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralMARKSANS PHARMA LIMITED25000-01125000-0011-0325000-0011-0725000-0011-27
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralStrides Pharma Science Limited64380-76364380-0763-0464380-0763-05
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralCamber Pharmaceuticals, Inc.31722-13131722-0131-3031722-0131-90

All 21 Dutasteride NDCs

Other NDCs under ANDA 209909

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

FDA NDC Directory listings under ANDA 209909
ProductStrengthForm · routeLabelerProduct NDC
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralEpic Pharma, LLC42806-549
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralA-S Medication Solutions50090-7852
DutasterideDutasteride .5 mg/1Capsule, Liquid filledOralNuCare Pharmaceuticals, Inc.68071-3857

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