Clobetasol Propionate NDC 33342-321

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-321Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0321Add 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
33342-321-39	33342032139	1 BOTTLE in 1 CARTON (33342-321-39) / 25 mL in 1 BOTTLEMarketed from Oct 8, 2021
33342-321-86	33342032186	1 BOTTLE in 1 CARTON (33342-321-86) / 50 mL in 1 BOTTLEMarketed from Nov 4, 2017

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): Clobetasol Propionate
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .4625 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209361
Marketing start: Nov 4, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 33342-321_7b4cca50-7139-4d48-8f4a-f8204fc46b2eSPL ID 7b4cca50-7139-4d48-8f4a-f8204fc46b2eSPL set ID 5ad9c808-6095-4d86-b140-e0f6d4079a3aUNII 779619577MUPC 0333342321398, 0333342321862
Pharmacologic class: Corticosteroid

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

N433342032139 followed by a unit qualifier and the quantity

Package 33342-0321-39. 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 Dec 23, 2022.

Indications (excerpt from the label)

INDICATIONS & USAGE Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209361

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

FDA NDC Directory listings under ANDA 209361
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .4625 mg/mL	SolutionTopical	A-S Medication Solutions	50090-5778