Prescription drug · ANDA
Clobetasol Propionate NDC 68462-532
Clobetasol propionate .5 mg/mL · Solution · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-532-28 | 68462053228 | 1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLEMarketed from Apr 18, 2018 | |
| 68462-532-53 | 68462053253 | 1 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLEMarketed from Apr 18, 2018 |
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/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210190
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-532_8a5a06f3-bb61-4854-8c74-673747cbcfddSPL ID 8a5a06f3-bb61-4854-8c74-673747cbcfddSPL set ID e37dd885-889a-4bfd-9813-bb7b9b96cee1RxCUI 861487UNII 779619577MUPC 0368462532287
- 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
N468462053228followed by a unit qualifier and the quantityPackage 68462-0532-28. 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 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.