Prescription drug · ANDA
Fluocinonide (Fluocinonide topical solution usp, 0.05%) NDC 63629-9583
Fluocinonide .5 mg/mL · Solution · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9583-1 | 63629958301 | 1 BOTTLE in 1 CARTON (63629-9583-1) / 60 mL in 1 BOTTLEMarketed from Dec 12, 2022 |
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 topical solution usp, 0.05%
- Active ingredients
- Fluocinonide — .5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209699
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-9583_d174142a-4f0d-4f7b-ab7d-c821590a2361SPL ID d174142a-4f0d-4f7b-ab7d-c821590a2361SPL set ID 38a36184-22b4-4e97-83e1-fdd984ef6ccbRxCUI 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
N463629958301followed by a unit qualifier and the quantityPackage 63629-9583-01. 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, 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.
About NDC 63629-9583
- What is NDC 63629-9583?
- 63629-9583 is the product NDC for Fluocinonide, Fluocinonide .5 mg/mL solution, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinonide (Fluocinonide topical solution usp, 0.05%).
- What is the active ingredient?
- Fluocinonide.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 |
Other NDCs under ANDA 209699
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 |
|---|---|---|---|---|
| Fluocinonidefluocinonide topical solution usp, 0.05% | Fluocinonide .5 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-001 |
| Fluocinonidefluocinonide topical solution usp, 0.05% | Fluocinonide .5 mg/mL | SolutionTopical | NuCare Pharmaceuticals, Inc. | 68071-3918 |
| Fluocinonidefluocinonide topical solution usp, 0.05% | Fluocinonide .5 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-1270 |