Clobetasol Propionate NDC 72578-085

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0085Add 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
72578-085-01	72578008501	1 BOTTLE in 1 CARTON (72578-085-01) / 59 mL in 1 BOTTLEMarketed from Apr 30, 2020
72578-085-02	72578008502	1 BOTTLE in 1 CARTON (72578-085-02) / 118 mL in 1 BOTTLEMarketed from Apr 30, 2020

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 — .05 g/100mL
Dosage form: Lotion
Route: Topical
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205249
Marketing start: Apr 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 72578-085_7885e4e8-e37e-4eaf-b632-f09f28f825cfSPL ID 7885e4e8-e37e-4eaf-b632-f09f28f825cfSPL set ID 2fc7de5f-094f-400c-b87e-750b16046f46RxCUI 861505UNII 779619577MUPC 0372578085018
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

N472578008501 followed by a unit qualifier and the quantity

Package 72578-0085-01. 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 Aug 16, 2024.

Indications (excerpt from the label)

Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older ( 1.1 ). Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Do not use if atrophy is present at the treatment site. ( 1.2 ) Do not use for rosacea or perioral dermatitis. ( 1.2 ) 1.1 Indication Clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205249

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

FDA NDC Directory listings under ANDA 205249
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .05 g/100mL	LotionTopical	Zydus Lifesciences Limited	70771-1498