olopatadine hydrochloride

Generic: olopatadine hydrochloride ophthalmic

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 ophthalmic
Labeler glenmark therapeutics inc., usa
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-168
Product ID 72657-168_bc82a9d3-2fd3-4a7d-9126-c0f07a610b05
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA200810
Listing Expiration 2027-12-31
Marketing Start 2024-07-26

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 72657168
Hyphenated Format 72657-168

Supplemental Identifiers

RxCUI
1111339
UPC
0372657168502
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 ophthalmic (source: ndc)
Application Number ANDA200810 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (72657-168-50) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

72657-168-50 1 BOTTLE, PLASTIC in 1 CARTON (72657-168-50) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 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": "bc82a9d3-2fd3-4a7d-9126-c0f07a610b05", "openfda": {"upc": ["0372657168502"], "unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["a80c3fd2-47b7-4ed0-b862-9c5099684607"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (72657-168-50)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "72657-168-50", "marketing_start_date": "20240726"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "72657-168_bc82a9d3-2fd3-4a7d-9126-c0f07a610b05", "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": "72657-168", "generic_name": "Olopatadine Hydrochloride ophthalmic", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA200810", "marketing_category": "ANDA", "marketing_start_date": "20240726", "listing_expiration_date": "20271231"}