Prescription drug · ANDA
Clodan (clobetasol propionate) NDC 43538-950
Clobetasol propionate .5 mg/mL · Shampoo · Topical · Medimetriks Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-950-04 | 43538095004 | 1 BOTTLE in 1 CARTON (43538-950-04) / 118 mL in 1 BOTTLEMarketed from Jun 22, 2014 |
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)
- Clodan
- Generic name (nonproprietary)
- clobetasol propionate
- Active ingredients
- Clobetasol propionate — .5 mg/mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- Medimetriks Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090974
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43538-950_d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51SPL ID d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51SPL set ID b5d32546-65dc-4b0c-826e-ddbc2a50b152RxCUI 861490, 1541099UNII 779619577MUPC 0343538950042
- 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
N443538095004followed by a unit qualifier and the quantityPackage 43538-0950-04. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090974
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 .05 g/100mL | ShampooTopical | Padagis Israel Pharmaceuticals Ltd | 45802-961 |
| clobetasol propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Bryant Ranch Prepack | 72162-1442 |
| clobetasol propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Bryant Ranch Prepack | 63629-9461 |