Over-the-counter drug · NDA
Flonase Sensimist Allergy Relief (fluticasone furoate) NDC 0135-0615
Fluticasone furoate 27.5 ug/1 · Spray, Metered · Nasal · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0615-01 | 00135061501 | 1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLEMarketed from Feb 1, 2017 | |
| 0135-0615-02 | 00135061502 | 1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLEMarketed from Feb 1, 2017 | |
| 0135-0615-03 | 00135061503 | 1 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Feb 1, 2017 | |
| 0135-0615-04 | 00135061504 | 3 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Feb 1, 2017 | |
| 0135-0615-05 | 00135061505 | 2 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Jul 1, 2017 | |
| 0135-0615-06 | 00135061506 | 1 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLEMarketed from Jan 22, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Flonase Sensimist Allergy ReliefSuffix: ALLERGY RELIEF
- Generic name (nonproprietary)
- fluticasone furoate
- Active ingredients
- Fluticasone furoate — 27.5 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Haleon US Holdings LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022051
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0135-0615_85fd731d-433f-4eba-aad8-6eda4550138eSPL ID 85fd731d-433f-4eba-aad8-6eda4550138eSPL set ID 107100af-7ca2-44e8-b067-c0ab0a19a6dcRxCUI 1797890, 1869712UNII JS86977WNV
- 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
N400135061501followed by a unit qualifier and the quantityPackage 00135-0615-01. 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 (for ages 12 and older)
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022051
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 |
|---|---|---|---|---|
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | Haleon US Holdings LLC | 0135-0616 |
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-5967 |
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-6075 |