Prescription drug · ANDA
Fluocinonide NDC 0713-0664
Fluocinonide .5 mg/g · Cream · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0664-15 | 00713066415 | 1 TUBE in 1 CARTON (0713-0664-15) / 15 g in 1 TUBEMarketed from Oct 9, 2018 | |
| 0713-0664-31 | 00713066431 | 1 TUBE in 1 CARTON (0713-0664-31) / 30 g in 1 TUBEMarketed from Oct 9, 2018 | |
| 0713-0664-60 | 00713066460 | 1 TUBE in 1 CARTON (0713-0664-60) / 60 g in 1 TUBEMarketed from Oct 9, 2018 |
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/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074204
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0713-0664_0abbc18e-8f87-0e6b-e063-6294a90a3685SPL ID 0abbc18e-8f87-0e6b-e063-6294a90a3685SPL set ID b28c444d-cb70-42c3-a437-c66ae961dbb4RxCUI 1801283UNII 2W4A77YPANUPC 0307130664608
- 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
N400713066415followed by a unit qualifier and the quantityPackage 00713-0664-15. 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% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 0713-0664
- What is NDC 0713-0664?
- 0713-0664 is the product NDC for Fluocinonide, Fluocinonide .5 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 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?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 |