What is NDC 71085-008?

71085-008 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by IPG PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

IPG PHARMACEUTICALS, INC., NDC labeler code 71085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ketoconazole?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ketoconazole NDC 71085-008 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71085-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71085-0008Add 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	Copy
71085-008-45	7108500084571085000845	1 TUBE in 1 CARTON (71085-008-45) / 45 g in 1 TUBEMarketed from Sep 10, 2026

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): Ketoconazole
Generic name (nonproprietary): ketoconazole
Active ingredients: Ketoconazole — 20 mg/g
Dosage form: Cream
Route: Topical
Labeler: IPG PHARMACEUTICALS, INC.NDC labeler code 71085
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075638
Marketing start: Sep 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 71085-008_5bc5a7b0-f5db-91b4-e063-6294a90aeeb1SPL ID 5bc5a7b0-f5db-91b4-e063-6294a90aeeb1
Pharmacologic class: Azole Antifungal

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471085000845 followed by a unit qualifier and the quantity

Package 71085-0008-45. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 71085-008

What is NDC 71085-008?: 71085-008 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by IPG PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ketoconazole.
What is the active ingredient?: Ketoconazole.
Who is the labeler?: IPG PHARMACEUTICALS, INC., NDC labeler code 71085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketoconazole?: 54 other product NDCs are listed under this name. See all Ketoconazole 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 Ketoconazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amerisyn LLC	87564-051	87564-0051-1087564-0051-30
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	NuCare Pharmaceuticals, Inc.	68071-5294	68071-5294-04
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Northstar Rx LLC	72603-878	72603-0878-01
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amici Pharma Inc.	69292-224	69292-0224-01
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Preferred Pharmaceuticals Inc.	68788-8868	68788-8868-01
Ketoconazole	Ketoconazole 20 mg/mL	ShampooTopical	Zydus Lifesciences Limited	70771-1874	70771-1874-07
Ketoconazole	Ketoconazole 20 mg/mL	ShampooTopical	Viona Pharmaceuticals Inc	72578-156	72578-0156-12
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Cosette Pharmaceuticals, Inc.	0713-0592	00713-0592-04
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	A-S Medication Solutions	50090-7538	50090-7538-00
Ketoconazoleketoconazole cream, 2%	Ketoconazole 20 mg/g	CreamTopical	REMEDYREPACK INC.	70518-4236	70518-4236-00

All 55 Ketoconazole NDCs

Other NDCs under ANDA 075638

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

FDA NDC Directory listings under ANDA 075638
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	NORTHSTAR RX LLC	16714-955
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	A-S Medication Solutions	50090-6069
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Golden State Medical Supply, Inc.	51407-279
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1298
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Proficient Rx LP	63187-774
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	NuCare Pharmaceuticals,Inc.	68071-1709