Prescription drug · ANDA
Fluocinonide NDC 76420-530
Fluocinonide 1 mg/g · Cream · Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-530-06 | 76420053006 | 1 TUBE in 1 CARTON (76420-530-06) / 60 g in 1 TUBEMarketed from Dec 13, 2022 | |
| 76420-530-12 | 76420053012 | 1 TUBE in 1 CARTON (76420-530-12) / 120 g in 1 TUBEMarketed from Dec 13, 2022 |
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 — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211111
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-530_efb3276f-d261-59b5-e053-2a95a90ab9fbSPL ID efb3276f-d261-59b5-e053-2a95a90ab9fbSPL set ID b387f926-1109-41b2-9fe0-f77db6b10280RxCUI 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
N476420053006followed by a unit qualifier and the quantityPackage 76420-0530-06. 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)
Fluocinonide Cream, 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, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years …
Excerpt only. Read the full label for complete information.
About NDC 76420-530
- What is NDC 76420-530?
- 76420-530 is the product NDC for Fluocinonide, Fluocinonide 1 mg/g cream, listed with the FDA by Asclemed USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinonide.
- What is the active ingredient?
- Fluocinonide.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluocinonide?
- 51 other product NDCs are listed under this name. See all Fluocinonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluocinonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | Saptalis Pharmaceuticals, LLC. | 71656-094 | 71656-0094-2071656-0094-60 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | NorthStar RxLLC | 72603-703 | 72603-0703-01 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-2490 | 72162-2490-0272162-2490-06 |
| Fluocinonide | Fluocinonide .5 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-761 | 45802-0761-1545802-0761-3045802-0761-60 |
| Fluocinonide | Fluocinonide .5 mg/mL | SolutionTopical | QUAGEN PHARMACEUTICALS LLC | 70752-154 | 70752-0154-05 |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-064 | 21922-0064-0321922-0064-0421922-0064-05+1 more |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8593 | 68788-8593-06 |
| Fluocinonide | Fluocinonide .5 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8554 | 68788-8554-06 |
| Fluocinonide | Fluocinonide .5 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0663 | 00713-0663-1500713-0663-3100713-0663-60 |
| Fluocinonide | Fluocinonide 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2508 | 63629-2508-01 |