Azelastine Hydrochloride NDC 60505-0578

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-0578Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-0578Add 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
60505-0578-4	60505057804	1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTICMarketed from Dec 1, 2009

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 — .5 mg/mL
Dosage form: Solution/ drops
Route: Intraocular
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078621
Marketing start: Dec 1, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 60505-0578_364ef1af-2b97-d1c6-7469-b76ba5567230SPL ID 364ef1af-2b97-d1c6-7469-b76ba5567230SPL set ID 77a33738-ffcf-221c-1562-780418882e5dRxCUI 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

N460505057804 followed by a unit qualifier and the quantity

Package 60505-0578-04. 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 Sep 8, 2026.

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)