Clotrimazole Topical Solution USP, 1% NDC 50228-502

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0502Add 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
50228-502-08	50228050208	1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLEMarketed from Oct 16, 2023
50228-502-30	50228050230	1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLEMarketed from Oct 16, 2023
50228-502-31	50228050231	1 BOTTLE in 1 CARTON (50228-502-31) / 30 mL in 1 BOTTLEMarketed from Oct 16, 2023

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): Clotrimazole Topical Solution USP, 1%
Generic name (nonproprietary): clotrimazole topical solution usp, 1%
Active ingredients: Clotrimazole — 10 mg/mL
Dosage form: Solution
Route: Topical
Labeler: ScieGen Pharmaceuticals, Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216569
Marketing start: Oct 16, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 50228-502_50b252b4-beb8-3d5a-e063-6394a90a3490SPL ID 50b252b4-beb8-3d5a-e063-6394a90a3490SPL set ID 15368c2a-572f-41fb-a3a1-7b1eb842faa8RxCUI 309370UNII G07GZ97H65UPC 0350228502306, 0350228502085, 0350228502313
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

N450228050208 followed by a unit qualifier and the quantity

Package 50228-0502-08. 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 Apr 30, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216569

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

FDA NDC Directory listings under ANDA 216569
Product	Strength	Form · route	Labeler	Product NDC
Clotrimazole Topical Solution USP, 1%	Clotrimazole 10 mg/mL	SolutionTopical	Allegis Holdings, LLC	71297-030
Clotrimazole Topical Solution USP, 1%	Clotrimazole 10 mg/mL	SolutionTopical	Akron Pharma Inc.	71399-0666
Clotrimazole	Clotrimazole 10 mg/mL	SprayTopical	AARNA USA INC	82568-0036