Prescription drug · ANDA
Fluocinolone acetonide NDC 45802-485
Fluocinolone acetonide .01 mg/100mL · Oil · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-485-26 | 45802048526 | 1 BOTTLE in 1 CARTON (45802-485-26) / 118.28 mL in 1 BOTTLEMarketed from Jun 14, 2017 |
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 — .01 mg/100mL
- Dosage form
- Oil
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202848
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-485_a42dc988-a62b-4c68-8736-f4a363ab4b35SPL ID a42dc988-a62b-4c68-8736-f4a363ab4b35SPL set ID 7f8512d9-b4a4-43c6-bac6-3e75dc451db2UNII 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
N445802048526followed by a unit qualifier and the quantityPackage 45802-0485-26. 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)
Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults. Fluocinolone acetonide topical oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202848
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 | Fluocinolone acetonide .01 mg/100mL | OilTopical | Bryant Ranch Prepack | 72162-1412 |
| Fluocinolone acetonide | Fluocinolone acetonide .01 mg/100mL | OilTopical | A-S Medication Solutions | 50090-7958 |
| Fluocinolone acetonide | Fluocinolone acetonide .01 mg/100mL | OilTopical | Bryant Ranch Prepack | 63629-8656 |