Prescription drug · ANDA
Clobetasol Propionate ANDA (clobetasol propionate) NDC 33342-506
Clobetasol propionate .5 mg/g · Ointment · Topical · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-506-15 | 33342050615 | 1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBEMarketed from Dec 28, 2023 | |
| 33342-506-30 | 33342050630 | 1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBEMarketed from Dec 28, 2023 | |
| 33342-506-45 | 33342050645 | 1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBEMarketed from Dec 28, 2023 | |
| 33342-506-60 | 33342050660 | 1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBEMarketed from Dec 28, 2023 |
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 ANDASuffix: ANDA
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215990
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 33342-506_92cf4231-e301-4353-98d9-85206ec6ba96SPL ID 92cf4231-e301-4353-98d9-85206ec6ba96SPL set ID 92cf4231-e301-4353-98d9-85206ec6ba96RxCUI 861448UNII 779619577MUPC 0333342506603, 0333342506306
- 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
N433342050615followed by a unit qualifier and the quantityPackage 33342-0506-15. 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 .
Indications (excerpt from the label)
INDICATIONS & USAGE Clobetasol propionate ointment is 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/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.
Other NDCs under ANDA 215990
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-8001 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | NorthStar RxLLC | 72603-855 |