Over-the-counter drug · NDA
Flonase Allergy Relief (Fluticasone propionate) NDC 0135-0576
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0576-01 | 0013505760100135057601 | 1 BOTTLE in 1 CARTON (0135-0576-01) / 30 SPRAY, METERED in 1 BOTTLEMarketed from Jun 30, 2016 | |
| 0135-0576-02 | 0013505760200135057602 | 1 BOTTLE in 1 PACKAGE (0135-0576-02) / 60 SPRAY, METERED in 1 BOTTLEMarketed from Dec 4, 2014 | |
| 0135-0576-03 | 0013505760300135057603 | 1 BOTTLE in 1 PACKAGE (0135-0576-03) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Dec 4, 2014 | |
| 0135-0576-04 | 0013505760400135057604 | 3 BOTTLE in 1 PACKAGE (0135-0576-04) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Jan 7, 2015 | |
| 0135-0576-12 | 0013505761200135057612 | 2 BOTTLE in 1 PACKAGE (0135-0576-12) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Feb 29, 2016 | |
| 0135-0576-14 | 0013505761400135057614 | 1 BOTTLE in 1 PACKAGE (0135-0576-14) / 144 SPRAY, METERED in 1 BOTTLEMarketed from Nov 17, 2016 | |
| 0135-0576-15 | 0013505761500135057615 | 2 BOTTLE in 1 PACKAGE (0135-0576-15) / 144 SPRAY, METERED in 1 BOTTLEMarketed from Mar 20, 2017 | |
| 0135-0576-16 | 0013505761600135057616 | 3 BOTTLE in 1 PACKAGE (0135-0576-16) / 144 SPRAY, METERED in 1 BOTTLEMarketed from Mar 20, 2017 | |
| 0135-0576-17 | 0013505761700135057617 | 1 BOTTLE in 1 PACKAGE (0135-0576-17) / 72 SPRAY, METERED in 1 BOTTLEMarketed from Jan 22, 2019 | |
| 0135-0576-18 | 0013505761800135057618 | 1 BOTTLE in 1 PACKAGE (0135-0576-18) / 90 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 Allergy ReliefSuffix: ALLERGY RELIEF
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 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 205434
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0135-0576_fe356980-6a1c-4830-b69c-7adb271b2e20SPL ID fe356980-6a1c-4830-b69c-7adb271b2e20SPL set ID b6134ba0-b70a-4eac-9a82-cef64b242c1dRxCUI 1797907, 1797933UNII O2GMZ0LF5W
- 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
N400135057601followed by a unit qualifier and the quantityPackage 00135-0576-01. 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 • itchy nose • runny nose • itchy, watery eyes • sneezing
Excerpt only. Read the full label for complete information.
About NDC 0135-0576
- What is NDC 0135-0576?
- 0135-0576 is the product NDC for Flonase Allergy Relief (fluticasone propionate), Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by Haleon US Holdings LLC. It has 10 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flonase Allergy Relief (Fluticasone propionate).
- What is the active ingredient?
- Fluticasone propionate.
- 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 Allergy Relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 205434
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 |
|---|---|---|---|---|
| Childrens Flonase Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Haleon US Holdings LLC | 0135-0582 |