Azelastine Hydrochloride NDC 68788-8514

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8514Add 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
68788-8514-2	68788851402	1 BOTTLE, SPRAY in 1 CARTON (68788-8514-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Sep 1, 2023

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: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212289
Marketing start: Sep 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-8514_9bc32bee-67cc-4e7c-a128-185235edc8c6SPL ID 9bc32bee-67cc-4e7c-a128-185235edc8c6SPL set ID 37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4RxCUI 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

N468788851402 followed by a unit qualifier and the quantity

Package 68788-8514-02. 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 11, 2026.

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. ()

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	A-S Medication Solutions	50090-7461
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