Prescription drug · ANDA
Fluocinolone Acetonide NDC 72162-2320
Fluocinolone acetonide .11 mg/mL · Oil · Auricular (Otic) · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2320-2 | 72162232002 | 1 BOTTLE in 1 CARTON (72162-2320-2) / 20 mL in 1 BOTTLEMarketed from May 20, 2024 |
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
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .11 mg/mL
- Dosage form
- Oil
- Route
- Auricular (Otic)
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212762
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72162-2320_e42c0c6a-991e-4e2e-96af-8e494d43cce3SPL ID e42c0c6a-991e-4e2e-96af-8e494d43cce3SPL set ID 7954bdec-1b75-41d1-8c19-500eceaf6655RxCUI 1191299UNII 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 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
N472162232002followed by a unit qualifier and the quantityPackage 72162-2320-02. 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)
INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212762
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 .11 mg/mL | OilAuricular (Otic) | Quagen Pharmaceuticals LLC | 70752-159 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Bryant Ranch Prepack | 71335-2879 |