Prescription drug · ANDA
Fluocinonide Cream (fluocinonide) NDC 69238-1534
Fluocinonide .5 mg/g · Cream · Topical · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1534-2 | 69238153402 | 1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBEMarketed from Oct 1, 2017 | |
| 69238-1534-3 | 69238153403 | 1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBEMarketed from Oct 1, 2017 | |
| 69238-1534-5 | 69238153405 | 1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBEMarketed from Oct 1, 2017 | |
| 69238-1534-6 | 69238153406 | 1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBEMarketed from Oct 1, 2017 |
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 Cream
- Generic name (nonproprietary)
- fluocinonide
- Active ingredients
- Fluocinonide — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210554
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69238-1534_64167760-d963-439f-ac85-21eefb5e8b39SPL ID 64167760-d963-439f-ac85-21eefb5e8b39SPL set ID 817cac6b-fec5-406d-aa0c-8852d08a3c65RxCUI 103456UNII 2W4A77YPANUPC 0369238153439
- 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
N469238153402followed by a unit qualifier and the quantityPackage 69238-1534-02. 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 Cream 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 210554
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/g | CreamTopical | A-S Medication Solutions | 50090-7923 |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-6309 |