Azelastine Hydrochloride NDC 68083-287

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-287Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0287Add 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
68083-287-01	68083028701	1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTICMarketed from Feb 25, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary): azelastine hydrochloride
Active ingredients: Azelastine hydrochloride — .5 mg/mL
Dosage form: Solution/ drops
Route: Intraocular
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210092
Marketing start: Feb 25, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68083-287_a29e9f18-dc8f-491a-b502-e26c0d8bfe08SPL ID a29e9f18-dc8f-491a-b502-e26c0d8bfe08SPL set ID f358cecd-284f-4d0b-806c-039465220bd2RxCUI 860805UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N468083028701 followed by a unit qualifier and the quantity

Package 68083-0287-01. 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 Oct 22, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210092

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

FDA NDC Directory listings under ANDA 210092
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride	Azelastine hydrochloride .5 mg/mL	Solution/ dropsIntraocular	Fosun Pharma USA Inc	72266-141