What is NDC 0093-3219?

0093-3219 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 0093-3219 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-3219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-3219Add 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
0093-3219-15	00093321915	1 TUBE in 1 CARTON (0093-3219-15) / 15 g in 1 TUBEMarketed from Feb 8, 2019
0093-3219-30	00093321930	1 TUBE in 1 CARTON (0093-3219-30) / 30 g in 1 TUBEMarketed from Feb 8, 2019
0093-3219-92	00093321992	1 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBEMarketed from Feb 8, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075581
Marketing start: Feb 8, 2019
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 0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0fSPL ID 3027539e-261c-4ac2-a25d-c41fcce3da0fSPL set ID 7fc47a6a-3714-4598-ae3b-d5a229262c21RxCUI 203088UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400093321915 followed by a unit qualifier and the quantity

Package 00093-3219-15. 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 Sep 2, 2021.

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 .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-3219

What is NDC 0093-3219?: 0093-3219 is the product NDC for Ketoconazole, Ketoconazole 20 mg/g cream, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 3 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?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 075581

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

FDA NDC Directory listings under ANDA 075581
Product	Strength	Form · route	Labeler	Product NDC
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	A-S Medication Solutions	50090-5265
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Bryant Ranch Prepack	63629-8819
Ketoconazole	Ketoconazole 20 mg/g	CreamTopical	Bryant Ranch Prepack	63629-8820