Clobetasol Propionate NDC 45802-925

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-925Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0925Add 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
45802-925-14	45802092514	1 TUBE in 1 CARTON (45802-925-14) / 15 g in 1 TUBEMarketed from Jul 30, 2008
45802-925-94	45802092594	1 TUBE in 1 CARTON (45802-925-94) / 30 g in 1 TUBEMarketed from Nov 11, 2008
45802-925-96	45802092596	1 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBEMarketed from Jul 31, 2008

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 — .5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075027
Marketing start: Jul 30, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-925_596d1122-15bb-4b30-b175-457ba7933a6eSPL ID 596d1122-15bb-4b30-b175-457ba7933a6eSPL set ID f9df643a-015d-4101-ac8f-c1e05b052df5RxCUI 861434UNII 779619577M
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

N445802092514 followed by a unit qualifier and the quantity

Package 45802-0925-14. 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 1, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075027

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

FDA NDC Directory listings under ANDA 075027
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .5 mg/g	GelTopical	Bryant Ranch Prepack	72162-1438
Clobetasol Propionate	Clobetasol propionate .5 mg/g	GelTopical	Bryant Ranch Prepack	63629-8637
Clobetasol Propionate	Clobetasol propionate .5 mg/g	GelTopical	Bryant Ranch Prepack	63629-8638
Clobetasol Propionate	Clobetasol propionate .5 mg/g	GelTopical	Bryant Ranch Prepack	63629-8639