clobetasol propionate emollient formulation NDC 45802-637

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-637Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0637Add 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
45802-637-32	45802063732	1 CAN in 1 CARTON (45802-637-32) / 50 g in 1 CANMarketed from Feb 1, 2013
45802-637-33	45802063733	1 CAN in 1 CARTON (45802-637-33) / 100 g in 1 CANMarketed from Feb 1, 2013

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 emollient formulationSuffix: emollient formulation
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .5 mg/g
Dosage form: Aerosol, Foam
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201402
Marketing start: Feb 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-637_7572ca02-83f9-4f88-b7a1-715eb5e1c56fSPL ID 7572ca02-83f9-4f88-b7a1-715eb5e1c56fSPL set ID 5264dfb8-3f6f-4f20-958d-9b5855806dc8RxCUI 1992273UNII 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

N445802063732 followed by a unit qualifier and the quantity

Package 45802-0637-32. 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, 2022.

Indications (excerpt from the label)

Clobetasol Propionate Foam, 0.05% (Emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. • Clobetasol Propionate Foam, 0.05% (Emulsion) is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201402

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

FDA NDC Directory listings under ANDA 201402
Product	Strength	Form · route	Labeler	Product NDC
Tovet (emollient formulation)clobetasol propionate	Clobetasol propionate .5 mg/g	Aerosol, FoamTopical	Medimetriks Pharmaceuticals, Inc.	43538-952