Azelastine Hydrochloride NDC 61314-308

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-308Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0308Add 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
61314-308-02	61314030802	1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 6 mL in 1 BOTTLE, PLASTICMarketed from Mar 21, 2013

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: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202305
Marketing start: Mar 21, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 61314-308_50b267f7-5553-45a4-a409-2d53417c5b39SPL ID 50b267f7-5553-45a4-a409-2d53417c5b39SPL set ID 6945fb86-27fb-4bab-8908-98772c6269c5RxCUI 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

N461314030802 followed by a unit qualifier and the quantity

Package 61314-0308-02. 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 Dec 11, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution, 0.05% 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)