What is NDC 69292-224?

69292-224 is the product NDC for Ketoconazole, Ketoconazole 200 mg/1 tablet, listed with the FDA by Amici Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Amici Pharma Inc., NDC labeler code 69292. 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 69292-224 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69292-224Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69292-0224Add 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
69292-224-01	6929202240169292022401	100 TABLET in 1 BOTTLE (69292-224-01)Marketed from Jun 21, 2025

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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amici Pharma Inc.NDC labeler code 69292
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075912
Marketing start: Jun 21, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 69292-224_82cd25ed-53c6-4897-bae0-d986d58f0cc8SPL ID 82cd25ed-53c6-4897-bae0-d986d58f0cc8SPL set ID 369f31da-d3c3-49b8-956f-f70598760164RxCUI 197853UNII R9400W927I
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469292022401 followed by a unit qualifier and the quantity

Package 69292-0224-01. 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 Jun 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the ce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69292-224

What is NDC 69292-224?: 69292-224 is the product NDC for Ketoconazole, Ketoconazole 200 mg/1 tablet, listed with the FDA by Amici Pharma 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?: Amici Pharma Inc., NDC labeler code 69292. 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 20 mg/g	CreamTopical	IPG PHARMACEUTICALS, INC.	71085-008	71085-0008-45
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 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 075912

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

FDA NDC Directory listings under ANDA 075912
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Burel Pharmaceuticals, LLC	35573-433
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	A-S Medication Solutions	50090-6142
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-1849
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Direct Rx	72189-180
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	Amerisyn LLC	87564-051