Prescription drug · ANDA
Fluocinolone Acetonide Oil (fluocinolone acetonide) NDC 64980-329
Fluocinolone acetonide .11 mg/mL · Oil · Auricular (Otic) · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-329-20 | 64980032920 | 20 mL in 1 BOTTLE (64980-329-20)Marketed from Sep 14, 2016 |
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 OilSuffix: Oil
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .11 mg/mL
- Dosage form
- Oil
- Route
- Auricular (Otic)
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203378
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3SPL ID 4e01be19-15cd-4b8f-bbae-158c27b556f3SPL set ID 79591576-1eab-48c5-b0a6-e205b3cc097eRxCUI 1191299UNII 0CD5FD6S2MUPC 0364980329200
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464980032920followed by a unit qualifier and the quantityPackage 64980-0329-20. 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 oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. Fluocinolone acetonide oil is a corticosteroid indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.