Prescription drug · ANDA
fluocinonide NDC 0168-0134
Fluocinonide .5 mg/mL · Solution · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0134-60 | 00168013460 | 1 BOTTLE in 1 CARTON (0168-0134-60) / 60 mL in 1 BOTTLEMarketed from Feb 27, 1995 |
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)
- fluocinonide
- Generic name (nonproprietary)
- fluocinonide
- Active ingredients
- Fluocinonide — .5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072934
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0134_e2784b8c-ca35-4719-8fca-169ecc08b529SPL ID e2784b8c-ca35-4719-8fca-169ecc08b529SPL set ID ebca0c66-06f6-438a-a01a-634c53debc06RxCUI 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
N400168013460followed by a unit qualifier and the quantityPackage 00168-0134-60. 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 072934
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 | Bryant Ranch Prepack | 72162-2146 |