olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler topco associates llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 76162-044
Product ID 76162-044_4dcb6552-c458-40c0-80f9-78ca2c668dfa
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209995
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

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 76162044
Hyphenated Format 76162-044

Supplemental Identifiers

RxCUI
1111343
UPC
0036800001176
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 ANDA209995 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (76162-044-39) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

76162-044-39 1 BOTTLE, PLASTIC in 1 CARTON (76162-044-39) / 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": "4dcb6552-c458-40c0-80f9-78ca2c668dfa", "openfda": {"upc": ["0036800001176"], "unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["1932ee68-43a5-6474-e063-6294a90aacaf"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (76162-044-39)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "76162-044-39", "marketing_start_date": "20200715"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "76162-044_4dcb6552-c458-40c0-80f9-78ca2c668dfa", "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": "76162-044", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA209995", "marketing_category": "ANDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}