Prescription drug · ANDA
Fluocinonide (Fluocinonide topical solution usp, 0.05%) NDC 21922-001
Fluocinonide .5 mg/mL · Solution · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-001-01 | 21922000101 | 1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLEMarketed from Apr 19, 2019 |
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 topical solution usp, 0.05%
- Active ingredients
- Fluocinonide — .5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- 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 21922-001_85d64cb1-93f5-480d-b454-ca43810c8539SPL ID 85d64cb1-93f5-480d-b454-ca43810c8539SPL set ID 4b1f775e-a7ad-4151-975e-6026296b5ceaRxCUI 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
N421922000101followed by a unit qualifier and the quantityPackage 21922-0001-01. 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 21922-001
- What is NDC 21922-001?
- 21922-001 is the product NDC for Fluocinonide, Fluocinonide .5 mg/mL solution, listed with the FDA by Encube Ethicals, Inc.. 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?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 | Bryant Ranch Prepack | 63629-9583 |
| 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 |