NDC 62332-598

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-598Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0598Add 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
62332-598-05	62332059805	1 BOTTLE in 1 CARTON (62332-598-05) / 5 mL in 1 BOTTLEMarketed from Jul 18, 2023
62332-598-10	62332059810	1 BOTTLE in 1 CARTON (62332-598-10) / 10 mL in 1 BOTTLEMarketed from Apr 5, 2023

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): Bepotastine Besilate Ophthalmic Solution 1.5%
Generic name (nonproprietary): bepotastine besilate ophthalmic solution 1.5%
Active ingredients: Bepotastine besilate — 15 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 214588
Marketing start: Apr 5, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 62332-598_ce72ab26-85a1-4fb5-a605-80bebe22f929SPL ID ce72ab26-85a1-4fb5-a605-80bebe22f929SPL set ID f68306a9-80ec-4bc5-8c00-1e1328f21e36RxCUI 863038UNII 6W18MO1QR3
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

N462332059805 followed by a unit qualifier and the quantity

Package 62332-0598-05. 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 Jul 21, 2023.

Indications (excerpt from the label)

Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching 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 214588

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

FDA NDC Directory listings under ANDA 214588
Product	Strength	Form · route	Labeler	Product NDC
Bepotastine Besilate Ophthalmic Solution 1.5%	Bepotastine besilate 15 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-598

Bepotastine Besilate Ophthalmic Solution 1.5% NDC 62332-598