Clobetasol Propionate NDC 42291-077

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-077Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0077Add 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
42291-077-15	42291007715	1 TUBE in 1 CARTON (42291-077-15) / 15 g in 1 TUBEMarketed from Jun 18, 2020
42291-077-30	42291007730	1 TUBE in 1 CARTON (42291-077-30) / 30 g in 1 TUBEMarketed from Jun 18, 2020
42291-077-45	42291007745	1 TUBE in 1 CARTON (42291-077-45) / 45 g in 1 TUBEMarketed from Jun 18, 2020
42291-077-60	42291007760	1 TUBE in 1 CARTON (42291-077-60) / 60 g in 1 TUBEMarketed from Jun 18, 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 — .5 mg/g
Dosage form: Ointment
Route: Topical
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209701
Marketing start: Jun 18, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 42291-077_ff958b19-2ce4-442a-e053-6294a90a66a0SPL ID ff958b19-2ce4-442a-e053-6294a90a66a0SPL set ID a862de41-1500-9136-e053-2a95a90a6080RxCUI 861448UNII 779619577MUPC 0348897077300
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

N442291007715 followed by a unit qualifier and the quantity

Package 42291-0077-15. 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 Jul 3, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Clobetasol Propionate Ointment USP 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. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209701

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

FDA NDC Directory listings under ANDA 209701
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	A-S Medication Solutions	50090-6402
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	Xiromed, LLC	70700-106