Prescription drug · ANDA
Fluocinolone Acetonide Topical Solution USP, 0.01% NDC 63629-9584
Fluocinolone acetonide .1 mg/mL · Solution · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9584-1 | 63629958401 | 1 BOTTLE in 1 CARTON (63629-9584-1) / 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)
- Fluocinolone Acetonide Topical Solution USP, 0.01%
- Generic name (nonproprietary)
- fluocinolone acetonide topical solution usp, 0.01%
- Active ingredients
- Fluocinolone acetonide — .1 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209913
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-9584_266c3c51-3913-4823-812b-7704a2caa570SPL ID 266c3c51-3913-4823-812b-7704a2caa570SPL set ID ce89966d-d7ea-4986-936e-6d46aee497cdRxCUI 1191310UNII 0CD5FD6S2M
- 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
N463629958401followed by a unit qualifier and the quantityPackage 63629-9584-01. 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 Fluocinolone Acetonide Topical Solution USP, 0.01% 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 209913
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 |
|---|---|---|---|---|
| Fluocinolone Acetonide Topical Solution USP, 0.01% | Fluocinolone acetonide .1 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-003 |
| Fluocinolone Acetonide Topical Solution USP, 0.01% | Fluocinolone acetonide .1 mg/mL | SolutionTopical | Bryant Ranch Prepack | 72162-1271 |