Prescription drug · ANDA

Ketoconazole (Ketoconazole cream, 2%) NDC 21922-025

Ketoconazole 20 mg/g · Cream · Topical · Encube Ethicals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)21922-025Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0025Add 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
21922-025-04219220025041 TUBE in 1 CARTON (21922-025-04) / 15 g in 1 TUBEMarketed from May 27, 2021
21922-025-05219220025051 TUBE in 1 CARTON (21922-025-05) / 30 g in 1 TUBEMarketed from May 27, 2021
21922-025-07219220025071 TUBE in 1 CARTON (21922-025-07) / 60 g in 1 TUBEMarketed from May 27, 2021

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 cream, 2%
Active ingredients
Ketoconazole — 20 mg/g
Dosage form
Cream
Route
Topical
Labeler
Encube Ethicals, Inc.NDC labeler code 21922
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212443
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 21922-025_21342f09-ce90-49aa-9660-63e01b602ab7SPL ID 21342f09-ce90-49aa-9660-63e01b602ab7SPL set ID 59188ef7-5bc9-4acc-bbff-8712c41e5f77RxCUI 203088UNII R9400W927IUPC 0321922025071, 0321922025057, 0321922025040
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

N421922002504 followed by a unit qualifier and the quantity

Package 21922-0025-04. 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)

INDICATIONS AND USAGE Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21922-025

What is NDC 21922-025?
21922-025 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by Encube Ethicals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ketoconazole (Ketoconazole Cream, 2%).
What is the active ingredient?
Ketoconazole.
Who is the labeler?
Encube Ethicals, Inc., NDC labeler code 21922. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
KetoconazoleKetoconazole 20 mg/gCreamTopicalIPG PHARMACEUTICALS, INC.71085-00871085-0008-45
KetoconazoleKetoconazole 200 mg/1TabletOralAmerisyn LLC87564-05187564-0051-1087564-0051-30
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalNuCare Pharmaceuticals, Inc.68071-529468071-5294-04
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalNorthstar Rx LLC72603-87872603-0878-01
KetoconazoleKetoconazole 200 mg/1TabletOralAmici Pharma Inc.69292-22469292-0224-01
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalPreferred Pharmaceuticals Inc.68788-886868788-8868-01
KetoconazoleKetoconazole 20 mg/mLShampooTopicalZydus Lifesciences Limited70771-187470771-1874-07
KetoconazoleKetoconazole 20 mg/mLShampooTopicalViona Pharmaceuticals Inc72578-15672578-0156-12
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalCosette Pharmaceuticals, Inc.0713-059200713-0592-04
KetoconazoleKetoconazole 20 mg/mLShampoo, SuspensionTopicalA-S Medication Solutions50090-753850090-7538-00

All 55 Ketoconazole NDCs

Other NDCs under ANDA 212443

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

FDA NDC Directory listings under ANDA 212443
ProductStrengthForm · routeLabelerProduct NDC
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalA-S Medication Solutions50090-6046
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalNuCare Pharmaceuticals,Inc.68071-3512
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-8233
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalREMEDYREPACK INC.70518-4236
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalProficient Rx LP82804-091
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalSportpharm LLC85766-135
Ketoconazoleketoconazole cream, 2%Ketoconazole 20 mg/gCreamTopicalASCLEMED USA INC.87063-066
Ketoconazole CreamKetoconazole 20 mg/gCreamTopicalDirect_Rx72189-422

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