Over-the-counter drug · NDA
Flonase Sensimist Allergy Relief (Fluticasone furoate) NDC 0135-0616
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 |
|---|---|---|---|
| 0135-0616-01 | 0013506160100135061601 | 1 BOTTLE in 1 PACKAGE (0135-0616-01) / 60 SPRAY, METERED in 1 BOTTLEMarketed from Jul 1, 2017 | |
| 0135-0616-03 | 0013506160300135061603 | 1 BOTTLE in 1 PACKAGE (0135-0616-03) / 72 SPRAY, METERED in 1 BOTTLEMarketed from Jul 1, 2021 |
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 LLCNDC labeler code 0135
- 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 0135-0616_6970c7c1-6d1e-42d1-a4e2-712b1bef7bc9SPL ID 6970c7c1-6d1e-42d1-a4e2-712b1bef7bc9SPL set ID 893234b5-be82-4425-b850-2b884637b18eRxCUI 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
N400135061601followed by a unit qualifier and the quantityPackage 00135-0616-01. 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.
About NDC 0135-0616
- What is NDC 0135-0616?
- 0135-0616 is the product NDC for Flonase Sensimist Allergy Relief (fluticasone furoate), Fluticasone furoate 27.5 ug/1 spray, metered, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flonase Sensimist Allergy Relief (Fluticasone furoate).
- What is the active ingredient?
- Fluticasone furoate.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flonase Sensimist Allergy Relief?
- 3 other product NDCs are listed under this name. See all Flonase Sensimist Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flonase Sensimist Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | Haleon US Holdings LLC | 0135-0615 | 00135-0615-0100135-0615-0200135-0615-03+3 more |
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-5967 | 50090-5967-00 |
| Flonase Sensimist Allergy Relieffluticasone furoate | Fluticasone furoate 27.5 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-6075 | 50090-6075-00 |
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 | 0135-0615 |
| 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 |