Prescription drug · NDA AUTHORIZED GENERIC
Fluocinolone Acetonide NDC 62559-299
Fluocinolone acetonide .25 mg/g · Ointment · Topical · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-299-15 | 62559029915 | 1 TUBE in 1 CARTON (62559-299-15) / 15 g in 1 TUBEMarketed from Nov 16, 2023 | |
| 62559-299-60 | 62559029960 | 1 TUBE in 1 CARTON (62559-299-60) / 60 g in 1 TUBEMarketed from Nov 16, 2023 |
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)
- Fluocinolone Acetonide
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .25 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 013960
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62559-299_ef1837eb-defb-4edd-a11c-824a890d5a95SPL ID ef1837eb-defb-4edd-a11c-824a890d5a95SPL set ID 622c9804-0be0-4dec-a6ba-5cf4b5578a84RxCUI 1191256UNII 0CD5FD6S2MUPC 0362559299152
- 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
N462559029915followed by a unit qualifier and the quantityPackage 62559-0299-15. 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 Fluocinolone Acetonide Ointment 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 NDA 013960
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 |
|---|---|---|---|---|
| Synalarfluocinolone acetonide | Fluocinolone acetonide .25 mg/g | OintmentTopical | Medimetriks Pharmaceuticals, Inc. | 43538-910 |