Prescription drug · ANDA
Flunisolide NDC 68682-344
Flunisolide .25 mg/mL · Solution · Nasal · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-344-25 | 68682034425 | 1 BOTTLE, PUMP in 1 CARTON (68682-344-25) / 25 mL in 1 BOTTLE, PUMPMarketed from Jun 1, 2025 |
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)
- Flunisolide
- Generic name (nonproprietary)
- flunisolide
- Active ingredients
- Flunisolide — .25 mg/mL
- Dosage form
- Solution
- Route
- Nasal
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074805
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68682-344_7e2cb3f0-5475-4c13-aadd-7cd14047a978SPL ID 7e2cb3f0-5475-4c13-aadd-7cd14047a978SPL set ID 50d87523-e1fb-4342-825f-9dba972c6a25RxCUI 1797863UNII QK4DYS664X
- 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468682034425followed by a unit qualifier and the quantityPackage 68682-0344-25. 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 Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074805
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 |
|---|---|---|---|---|
| Flunisolide | Flunisolide .25 mg/mL | SolutionNasal | Bausch & Lomb Incorporated | 24208-344 |