NDC codes

FDA NDC Directory
Product NDC (as listed)50090-0549Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-0549Add 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 NDC11-digit (billing)PackageCopy
50090-0549-0500900549001 TUBE in 1 CARTON (50090-0549-0) / 15 g in 1 TUBEMarketed from Jun 29, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074249
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 50090-0549_36af3c6c-0322-48c8-8261-e6689cf37c88SPL ID 36af3c6c-0322-48c8-8261-e6689cf37c88SPL set ID ecef6314-97c0-4f2e-bbcb-53a62ac7fb72RxCUI 861495UNII 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

N450090054900 followed by a unit qualifier and the quantity

Package 50090-0549-00. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations 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 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 neces…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074249

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

FDA NDC Directory listings under ANDA 074249
ProductStrengthForm · routeLabelerProduct NDC
Clobetasol PropionateClobetasol propionate .5 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-1258

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