Olopatadine Hydrochloride NDC 72657-194

NDC codes

FDA NDC Directory

Product NDC (as listed)72657-194Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72657-0194Add 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
72657-194-11	72657019411	2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2025
72657-194-25	72657019425	1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Feb 28, 2025

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): Olopatadine Hydrochloride
Generic name (nonproprietary): olopatadine hydrochloride
Active ingredients: Olopatadine hydrochloride — 2 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: GLENMARK THERAPEUTICS INC., USA
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219557
Marketing start: Feb 28, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 72657-194_5ce14b14-b893-4d56-a19e-b1788b17074fSPL ID 5ce14b14-b893-4d56-a19e-b1788b17074fSPL set ID 07e8b359-d4ae-4b5b-81dc-c7e57e172c58RxCUI 1111343UNII 2XG66W44KFUPC 0372657194259
Pharmacologic class: Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer

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

N472657019411 followed by a unit qualifier and the quantity

Package 72657-0194-11. 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 27, 2026.

Indications (excerpt from the label)

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219557

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

FDA NDC Directory listings under ANDA 219557
Product	Strength	Form · route	Labeler	Product NDC
Olopatadine Hydrochloride	Olopatadine hydrochloride 2 mg/mL	SolutionOphthalmic	AmerisourceBergen Drug Corp	46122-824
Eye Allergy Itch Relief	Olopatadine hydrochloride 2 mg/mL	Solution/ dropsOphthalmic	Allegiant Health	69168-495
Olopatadine Hydrochloride	Olopatadine hydrochloride 2 mg/mL	SolutionOphthalmic	BluePoint Laboratories	68001-674
Olopatadine Hydrochloride	Olopatadine hydrochloride 2 mg/mL	SolutionOphthalmic	YYBA Corp	73581-709