Prescription drug · ANDA
Fluocinonide NDC 43386-026
Fluocinonide .5 mg/mL · Solution · Topical · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-026-02 | 43386002602 | 1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLEMarketed from Jul 21, 2017 | |
| 43386-026-06 | 43386002606 | 1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLEMarketed from Jul 21, 2017 |
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)
- Fluocinonide
- Generic name (nonproprietary)
- fluocinonide
- Active ingredients
- Fluocinonide — .5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206003
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43386-026_465101b9-6374-4ce8-b64d-97e296f5c72aSPL ID 465101b9-6374-4ce8-b64d-97e296f5c72aSPL set ID 43b7621c-6628-4b54-af32-32efd0f722daRxCUI 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
N443386002602followed by a unit qualifier and the quantityPackage 43386-0026-02. 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 Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206003
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 | Novel Laboratories, Inc. | 40032-026 |