Prescription drug · ANDA
Fluocinonide NDC 70771-1375
Fluocinonide .5 mg/mL · Solution · Topical · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1375-3 | 70771137503 | 60 mL in 1 BOTTLE (70771-1375-3)Marketed from Nov 1, 2018 | |
| 70771-1375-8 | 70771137508 | 20 mL in 1 BOTTLE (70771-1375-8)Marketed from Nov 1, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Fluocinonide
- Generic name (nonproprietary)
- fluocinonide
- Active ingredients
- Fluocinonide — .5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208948
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70771-1375_1a414d04-9c98-460f-8c89-93b98698206eSPL ID 1a414d04-9c98-460f-8c89-93b98698206eSPL set ID 72b19e31-49e8-4bd7-8205-997f0c6a43f1RxCUI 310364UNII 2W4A77YPAN
- 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
N470771137503followed by a unit qualifier and the quantityPackage 70771-1375-03. 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 .
Other NDCs under ANDA 208948
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 |
|---|---|---|---|---|
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | Zydus Pharmaceuticals USA Inc. | 70710-1284 |