NDC 0378-3458

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3458Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3458Add 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 NDC	11-digit (billing)	Package	Copy
0378-3458-23	00378345823	1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Apr 14, 2020

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): Azelastine Hydrochloride and Fluticasone Propionate
Generic name (nonproprietary): azelastine hydrochloride and fluticasone propionate
Active ingredients: Azelastine hydrochloride — 137 ug/1Fluticasone propionate — 50 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 202236
Marketing start: Apr 14, 2020
Marketing end: Feb 28, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aaSPL ID 6e1e173a-2d01-4e67-8361-dd30604bc8aaSPL set ID 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9eRxCUI 1797847UNII 0L591QR10I, O2GMZ0LF5W
Pharmacologic class: Corticosteroid; Histamine-1 Receptor Antagonist

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

N400378345823 followed by a unit qualifier and the quantity

Package 00378-3458-23. 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 Dec 15, 2024.

Indications (excerpt from the label)

Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202236

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 202236
Product	Strength	Form · route	Labeler	Product NDC
Dymistaazelastine hydrochloride and fluticasone propionate	Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Viatris Specialty LLC	0037-0245

Azelastine Hydrochloride and Fluticasone Propionate NDC 0378-3458