Clobetasol Propionate NDC 68462-530

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-530Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0530Add 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
68462-530-17	68462053017	1 TUBE in 1 CARTON (68462-530-17) / 15 g in 1 TUBEMarketed from Mar 20, 2017
68462-530-35	68462053035	1 TUBE in 1 CARTON (68462-530-35) / 30 g in 1 TUBEMarketed from Mar 20, 2017
68462-530-47	68462053047	1 TUBE in 1 CARTON (68462-530-47) / 45 g in 1 TUBEMarketed from Mar 20, 2017
68462-530-65	68462053065	1 TUBE in 1 CARTON (68462-530-65) / 60 g in 1 TUBEMarketed from Mar 20, 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 — .5 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208933
Marketing start: Mar 20, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68462-530_923024a2-fbce-4487-872f-98e4016183c3SPL ID 923024a2-fbce-4487-872f-98e4016183c3SPL set ID 420deed6-321f-4a2a-9042-1e61636621aaRxCUI 861448UNII 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

N468462053017 followed by a unit qualifier and the quantity

Package 68462-0530-17. 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 26, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clobetasol propionate ointment 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 grams per 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 208933

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

FDA NDC Directory listings under ANDA 208933
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	Northstar Rx LLC	16714-782
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	A-S Medication Solutions	50090-5488