Azelastine Hydrochloride Ophthalmic Solution 0.05% NDC 62332-506

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-506Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0506Add 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
62332-506-06	62332050606	1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLEMarketed from Mar 20, 2019

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 Ophthalmic Solution 0.05%
Generic name (nonproprietary): azelastine hydrochloride ophthalmic solution 0.05%
Active ingredients: Azelastine hydrochloride — .5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209620
Marketing start: Mar 20, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 62332-506_0857a4e2-caec-4c87-9894-949a549144c3SPL ID 0857a4e2-caec-4c87-9894-949a549144c3SPL set ID 7532ed82-5cfa-49da-83e5-c57ffdd3adbbRxCUI 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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462332050606 followed by a unit qualifier and the quantity

Package 62332-0506-06. 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 Jan 2, 2025.

Indications (excerpt from the label)

INDICATIONS & 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)

Other NDCs under ANDA 209620

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

FDA NDC Directory listings under ANDA 209620
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride	Azelastine hydrochloride .5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-506