Ketoconazole NDC 70954-662

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-662Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0662Add 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
70954-662-10	70954066210	120 mL in 1 BOTTLE, PLASTIC (70954-662-10)Marketed from Sep 16, 2024

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/mL
Dosage form: Shampoo
Route: Topical
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218498
Marketing start: Sep 16, 2024
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 70954-662_8aec6ed1-af2d-415f-bb5f-e56da3045debSPL ID 8aec6ed1-af2d-415f-bb5f-e56da3045debSPL set ID 00c1cac8-a865-4583-aaba-3a0f21fb31e6RxCUI 106336UNII R9400W927IUPC 0370954662105
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

N470954066210 followed by a unit qualifier and the quantity

Package 70954-0662-10. 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 Jan 29, 2026.

Indications (excerpt from the label)

INDICATIONS & USAGE Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur bec…

Excerpt only. Read the full label for complete information.

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