Prescription drug · ANDA
Fluticasone Propionate NDC 63187-638
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-638-16 | 63187063816 | 1 BOTTLE, SPRAY in 1 CARTON (63187-638-16) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Dec 1, 2018 |
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)
- Fluticasone Propionate
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077538
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63187-638_d97bc166-af2e-4d41-9669-fd7f46f84f23SPL ID d97bc166-af2e-4d41-9669-fd7f46f84f23SPL set ID 1d5d5f27-6565-4e7b-9923-faa3d15cb1c4RxCUI 1797907UNII O2GMZ0LF5WUPC 0363187638160
- 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
N463187063816followed by a unit qualifier and the quantityPackage 63187-0638-16. 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 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 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 077538
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 | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Golden State Medical Supply, Inc. | 60429-195 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-0968 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals, Inc. | 68788-9678 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | IPG Pharmaceuticals, Inc. | 71085-090 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | REMEDYREPACK INC. | 70518-1655 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Quality Care Products, LLC | 55700-714 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-0829 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Direct_RX | 72189-004 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Asclemed USA, Inc. | 76420-903 |