Over-the-counter drug · ANDA
Fluticasone Propionate NDC 63654-380
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · Selder, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63654-380-01 | 6365403800163654038001 | 1 BOTTLE, SPRAY in 1 CARTON (63654-380-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from May 17, 2017 |
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
- Selder, S.A. de C.V.NDC labeler code 63654
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208150
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63654-380_9519d5f7-acd5-4700-9738-08cef7e54083SPL ID 9519d5f7-acd5-4700-9738-08cef7e54083SPL set ID 2da4ba91-c356-473d-b20c-5bb9265767dfRxCUI 1797907UNII O2GMZ0LF5WUPC 0645981000320
- 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
N463654038001followed by a unit qualifier and the quantityPackage 63654-0380-01. 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)
Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose itchy, watery eyes
Excerpt only. Read the full label for complete information.
About NDC 63654-380
- What is NDC 63654-380?
- 63654-380 is the product NDC for Fluticasone Propionate, Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by Selder, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluticasone Propionate.
- What is the active ingredient?
- Fluticasone propionate.
- Who is the labeler?
- Selder, S.A. de C.V., NDC labeler code 63654. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluticasone Propionate?
- 59 other product NDCs are listed under this name. See all Fluticasone Propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluticasone Propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | YYBA Corp | 73581-510 | 73581-0510-0173581-0510-03 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Glenmark Pharmaceuticals Inc., USA | 68462-918 | 68462-0918-2068462-0918-4468462-0918-60+1 more |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-350 | 59726-0350-3859726-0350-54 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Chain Drug Marketing Association, Inc. | 83324-294 | 83324-0294-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Family Dollar Stores, LLC | 55319-058 | 55319-0058-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | SprayNasal | Preferred Pharmaceuticals Inc. | 68788-4120 | 68788-4120-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-014 | 69168-0014-01 |
| Fluticasone Propionate | Fluticasone propionate 44 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Glenmark Pharmaceuticals Inc., USA | 68462-937 | 68462-0937-20 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Grocery Outlet | 85828-448 | 85828-0448-01 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | IPG Pharmaceuticals, Inc. | 71085-090 | 71085-0090-1671085-0090-32 |
Other NDCs under ANDA 208150
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 |
|---|---|---|---|---|
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Discount Drug Mart | 53943-006 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Quality Home Products | 64525-6560 |
| Allergy Relief Nasal | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Marc Glassman, Inc. | 68998-452 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreens | 0363-0652 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | The Kroger Co. | 30142-258 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walmart | 49035-362 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | TWIN MED LLC | 55681-389 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-350 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-0955 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-6205 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Sam's West Inc. | 68196-210 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Sam's West, Inc | 68196-503 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-014 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-380 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-448 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Allegiant Health | 69168-452 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Chain Drug Marketing Association, Inc. | 83324-294 |
| Fluticasone Propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Grocery Outlet | 85828-448 |