NDC codes

FDA NDC Directory
Product NDC (as listed)0135-0582Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00135-0582Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0135-0582-04001350582041 BOTTLE in 1 PACKAGE (0135-0582-04) / 72 SPRAY, METERED in 1 BOTTLEMarketed from Feb 29, 2016

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)
Childrens 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 0135-0582_19c67359-3ee5-440b-82c3-efa11b775cdbSPL ID 19c67359-3ee5-440b-82c3-efa11b775cdbSPL set ID fab7a1f4-75e0-416f-9644-07aff08e6ab0RxCUI 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

N400135058204 followed by a unit qualifier and the quantity

Package 00135-0582-04. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0135-0582

What is NDC 0135-0582?
0135-0582 is the product NDC for Childrens Flonase Allergy Relief (fluticasone propionate), Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens 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 Childrens 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.

FDA NDC Directory listings under NDA 205434
ProductStrengthForm · routeLabelerProduct NDC
Flonase Allergy Relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalHaleon US Holdings LLC0135-0576

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