olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler glenmark therapeutics inc., usa
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-194
Product ID 72657-194_5ce14b14-b893-4d56-a19e-b1788b17074f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA219557
Listing Expiration 2027-12-31
Marketing Start 2025-02-28

Pharmacologic Class

Classes
decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] histamine-1 receptor inhibitor [epc] mast cell stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72657194
Hyphenated Format 72657-194

Supplemental Identifiers

RxCUI
1111343
UPC
0372657194259
UNII
2XG66W44KF

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olopatadine hydrochloride (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number ANDA219557 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

72657-194-11 2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11) / 2.5 mL in 1 BOTTLE, PLASTIC 72657-194-25 1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25) / 2.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

OLOPATADINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "5ce14b14-b893-4d56-a19e-b1788b17074f", "openfda": {"upc": ["0372657194259"], "unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["07e8b359-d4ae-4b5b-81dc-c7e57e172c58"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CARTON (72657-194-11)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "72657-194-11", "marketing_start_date": "20250228"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (72657-194-25)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "72657-194-25", "marketing_start_date": "20250228"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "72657-194_5ce14b14-b893-4d56-a19e-b1788b17074f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Histamine-1 Receptor Inhibitor [EPC]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "72657-194", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA219557", "marketing_category": "ANDA", "marketing_start_date": "20250228", "listing_expiration_date": "20271231"}