Prescription drug · ANDA
Clobetasol Propionate NDC 68462-480
Clobetasol propionate .05 g/mL · Spray · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-480-39 | 68462048039 | 1 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLEMarketed from Mar 26, 2018 | |
| 68462-480-56 | 68462048056 | 1 BOTTLE in 1 CARTON (68462-480-56) / 125 mL in 1 BOTTLEMarketed from Mar 26, 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 — .05 g/mL
- Dosage form
- Spray
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209004
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-480_a827f327-e5a8-4162-9f5a-1215bcb449ecSPL ID a827f327-e5a8-4162-9f5a-1215bcb449ecSPL set ID dfc58f73-e892-4fc3-8726-4e8d1546ebd3RxCUI 861512UNII 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
N468462048039followed by a unit qualifier and the quantityPackage 68462-0480-39. 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)
Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. ( 1.1 ) Limitations of Use: • Do not use on the face, axillae or groin. ( 1.2 ) • Do not use if atrophy is present at the treatment site. ( 1.2 ) • Do not use for rosacea or perioral dermatitis. ( 1.2 ) 1.1 Indication Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructe…
Excerpt only. Read the full label for complete information.