What is NDC 64380-827?

64380-827 is the product NDC for Ketoconazole, Ketoconazole 200 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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?

56 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 64380-827 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-827Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0827Add 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
64380-827-06	64380082706	100 TABLET in 1 BOTTLE (64380-827-06)Marketed from Jun 26, 2018
64380-827-07	64380082707	500 TABLET in 1 BOTTLE (64380-827-07)Marketed from Jun 26, 2018

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: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210457
Marketing start: Jun 26, 2018
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 64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6bSPL ID 9781ff7c-39a7-4c61-a6ec-7f1947685c6bSPL set ID 6d4be760-c723-4f54-a854-12c61cf91703RxCUI 197853UNII R9400W927IUPC 0364380827061
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

N464380082706 followed by a unit qualifier and the quantity

Package 64380-0827-06. 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 Dec 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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 cere…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-827

What is NDC 64380-827?: 64380-827 is the product NDC for Ketoconazole, Ketoconazole 200 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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?: 56 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	Northstar Rx LLC	72603-878	72603-0878-01
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	NuCare Pharmaceuticals, Inc.	68071-5294	68071-5294-04
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	A-S Medication Solutions	50090-7538	50090-7538-00
Ketoconazole	Ketoconazole 20 mg/mL	Shampoo, SuspensionTopical	Cosette Pharmaceuticals, Inc.	0713-0592	00713-0592-04

All 57 Ketoconazole NDCs

Other NDCs under ANDA 210457

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

FDA NDC Directory listings under ANDA 210457
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 200 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-052