Prescription drug · ANDA
Fluticasone (fluticasone propionate) NDC 68071-1638
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-1638-5 | 68071163805 | 16 SPRAY, METERED in 1 BOX (68071-1638-5)Marketed from Jul 18, 2017 |
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)
- Fluticasone
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078492
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68071-1638_1d4de18d-941b-bcf1-e063-6394a90a628dSPL ID 1d4de18d-941b-bcf1-e063-6394a90a628dSPL set ID 549ff4f2-fa68-3dd8-e054-00144ff8d46cRxCUI 1797907UNII O2GMZ0LF5WUPC 0368071163858
- 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
N468071163805followed by a unit qualifier and the quantityPackage 68071-1638-05. 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)
Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078492
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 |
|---|---|---|---|---|
| Fluticasone Propionate spray, meteredfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Chartwell RX, LLC | 62135-810 |