Clotrimazole NDC 82568-0036

NDC codes

FDA NDC Directory

Product NDC (as listed)82568-0036Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82568-0036Add 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
82568-0036-1	82568003601	1 BOTTLE in 1 CARTON (82568-0036-1) / 10 mL in 1 BOTTLEMarketed from Oct 16, 2023
82568-0036-3	82568003603	1 BOTTLE in 1 CARTON (82568-0036-3) / 30 mL in 1 BOTTLEMarketed from Oct 16, 2023
82568-0036-6	82568003606	2 BOTTLE in 1 CARTON (82568-0036-6) / 30 mL in 1 BOTTLEMarketed from Mar 9, 2024

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/mL
Dosage form: Spray
Route: Topical
Labeler: AARNA USA 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 82568-0036_4bd825f4-f5e3-aab7-e063-6394a90ad6a4SPL ID 4bd825f4-f5e3-aab7-e063-6394a90ad6a4SPL set ID 4bd825f4-f5e2-aab7-e063-6394a90ad6a4RxCUI 358371UNII G07GZ97H65UPC 0382568003618, 0382568003632
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

N482568003601 followed by a unit qualifier and the quantity

Package 82568-0036-01. 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 Feb 27, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution Spray 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	ScieGen Pharmaceuticals, Inc	50228-502
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