Prescription drug · ANDA
Fluocinonide NDC 51672-1353
Fluocinonide 1 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1353-2 | 51672135302 | 1 TUBE in 1 CARTON (51672-1353-2) / 30 g in 1 TUBEMarketed from Jul 14, 2014 | |
| 51672-1353-3 | 51672135303 | 1 TUBE in 1 CARTON (51672-1353-3) / 60 g in 1 TUBEMarketed from Jul 14, 2014 | |
| 51672-1353-4 | 51672135304 | 1 TUBE in 1 CARTON (51672-1353-4) / 120 g in 1 TUBEMarketed from Jul 14, 2014 |
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 — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200734
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-1353_390c3bf3-dd9d-f100-e063-6294a90a81f1SPL ID 390c3bf3-dd9d-f100-e063-6294a90a81f1SPL set ID 16c7d142-e695-4e33-986f-78cb37f7b387RxCUI 485647UNII 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
N451672135302followed by a unit qualifier and the quantityPackage 51672-1353-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) Avoid use on the face, groin, or axillae. ( 1.2 ) Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patie…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200734
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 1 mg/g | CreamTopical | Asclemed USA, Inc. | 76420-509 |