Prescription drug · ANDA
Clobetasol Propionate NDC 13668-569
Clobetasol propionate .5 mg/g · Cream · Topical · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-569-01 | 13668056901 | 15 g in 1 TUBE (13668-569-01)Marketed from Dec 15, 2024 | |
| 13668-569-02 | 13668056902 | 30 g in 1 TUBE (13668-569-02)Marketed from Dec 15, 2024 | |
| 13668-569-04 | 13668056904 | 45 g in 1 TUBE (13668-569-04)Marketed from Dec 15, 2024 | |
| 13668-569-05 | 13668056905 | 60 g in 1 TUBE (13668-569-05)Marketed from Dec 15, 2024 |
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
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211836
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 13668-569_e105f3a8-2dee-4547-9760-35e7a1da464aSPL ID e105f3a8-2dee-4547-9760-35e7a1da464aSPL set ID 6f930298-e410-4bfb-8c3f-456a1f55f4a9RxCUI 861495UNII 779619577MUPC 0313668569018
- 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
N413668056901followed by a unit qualifier and the quantityPackage 13668-0569-01. 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 cream USP is 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.