Prescription drug · ANDA
Fluocinonide NDC 21922-001
fluocinonide topical solution usp, 0.05% · 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.
- 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.
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 | NuCare Pharmaceuticals, Inc. | 68071-3918 |
| Fluocinonidefluocinonide topical solution usp, 0.05% | Fluocinonide .5 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-1270 |
| Fluocinonidefluocinonide topical solution usp, 0.05% | Fluocinonide .5 mg/mL | SolutionTopical | Bryant Ranch Prepack | 63629-9583 |