Clotrimazole NDC 68788-8491

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8491Add 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
68788-8491-4	68788849104	1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jul 24, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Clotrimazole
Generic name (nonproprietary): clotrimazole
Active ingredients: Clotrimazole — 10 mg/g
Dosage form: Cream
Route: Vaginal
Labeler: Preferred Pharmaceuticals Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074165
Marketing start: Jul 24, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 68788-8491_ebbd70fb-8dd2-4bc8-b814-1e346558565aSPL ID ebbd70fb-8dd2-4bc8-b814-1e346558565aSPL set ID fd010006-f646-46ed-841a-9f247b19e397RxCUI 309368UNII G07GZ97H65
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N468788849104 followed by a unit qualifier and the quantity

Package 68788-8491-04. 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 Mar 31, 2026.

Indications (excerpt from the label)

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074165

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

FDA NDC Directory listings under ANDA 074165
Product	Strength	Form · route	Labeler	Product NDC
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	A-S Medication Solutions	50090-7376
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Walgreens	0363-0220
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Strategic Sourcing Services LLC	49348-793
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	H2-Pharma, LLC	61269-220
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Preferred Pharmaceuticals Inc.	68788-8330
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	QUALITY CHOICE (Chain Drug Marketing Association)	83324-154
Clotrimazole	Clotrimazole 10 mg/g	CreamVaginal	Cardinal Health (Leader) 70000	70000-0729