Prescription drug · ANDA
Clobetasol Propionate NDC 0168-0269
Clobetasol propionate .5 mg/mL · Solution · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0269-50 | 00168026950 | 50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)Marketed from Feb 8, 1999 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075391
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0269_3ae739b7-7eaa-4dbd-a696-a3a0e3998f38SPL ID 3ae739b7-7eaa-4dbd-a696-a3a0e3998f38SPL set ID 736325f3-a369-4d70-b608-3d6ba37b6a6bRxCUI 861487UNII 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
N400168026950followed by a unit qualifier and the quantityPackage 00168-0269-50. 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 topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.
Excerpt only. Read the full label for complete information.