Azelastine Hydrochloride And Fluticasone Propionate NDC 63629-8612

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8612Add 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
63629-8612-1	63629861201	1 BOTTLE in 1 CARTON (63629-8612-1) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Mar 1, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, fluticasone propionate
Active ingredients: Azelastine hydrochloride — 137 ug/1Fluticasone propionate — 50 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208111
Marketing start: Mar 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63629-8612_2cb5fed9-e2fc-448c-87df-83af32f6bc78SPL ID 2cb5fed9-e2fc-448c-87df-83af32f6bc78SPL set ID 1a930a09-db26-40aa-bb05-123a0d7182bcRxCUI 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

N463629861201 followed by a unit qualifier and the quantity

Package 63629-8612-01. 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 Mar 27, 2025.

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 ANDA 208111

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

FDA NDC Directory listings under ANDA 208111
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride And Fluticasone Propionateazelastine hydrochloride, fluticasone propionate	Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Bryant Ranch Prepack	72162-1388
Azelastine Hydrochloride And Fluticasone Propionateazelastine hydrochloride, fluticasone propionate	Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Padagis Israel Pharmaceuticals Ltd	45802-066