Azelastine Hydrochloride NDC 50090-7461

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-7461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-7461Add 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
50090-7461-0	50090746100	1 BOTTLE, SPRAY in 1 CARTON (50090-7461-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Nov 19, 2024

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
Generic name (nonproprietary): azelastine hydrochloride
Active ingredients: Azelastine hydrochloride — 137 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212289
Marketing start: May 8, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 50090-7461_6f0629d0-5f20-406f-ad61-cf775f553772SPL ID 6f0629d0-5f20-406f-ad61-cf775f553772SPL set ID fc9d031d-428d-4d53-8e63-feb96d5ab01aRxCUI 1797867UNII 0L591QR10I
Pharmacologic class: 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

N450090746100 followed by a unit qualifier and the quantity

Package 50090-7461-00. 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 Nov 20, 2024.

Indications (excerpt from the label)

Azelastine hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride Nasal Spray is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years 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 212289

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

FDA NDC Directory listings under ANDA 212289
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	Preferred Pharmaceuticals Inc.	68788-8514
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	NorthStar Rx LLC	72603-611
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	Aurobindo Pharma Limited	59651-214