Prescription drug · ANDA
Amcinonide NDC 0168-0278
Amcinonide 1 mg/g · Cream · Topical · Fougera Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0278-15 | 00168027815 | 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBEMarketed from May 15, 2003 | |
| 0168-0278-30 | 00168027830 | 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBEMarketed from May 15, 2003 | |
| 0168-0278-60 | 00168027860 | 1 TUBE in 1 CARTON (0168-0278-60) / 60 g in 1 TUBEMarketed from May 15, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Amcinonide
- Generic name (nonproprietary)
- amcinonide
- Active ingredients
- Amcinonide — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Fougera Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076065
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0278_51093468-b64d-4b34-9627-8e6313c8265eSPL ID 51093468-b64d-4b34-9627-8e6313c8265eSPL set ID 8aefa477-ac2c-41c8-a807-d24522aed8f0RxCUI 197327UNII 423W026MA9UPC 0301680278155
- 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
N400168027815followed by a unit qualifier and the quantityPackage 00168-0278-15. 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 AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.