olopatadine hydrochloride ophthalmic solution

Generic: olopatadine hydrochloride ophthalmic

Labeler: gland pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride ophthalmic solution
Generic Name olopatadine hydrochloride ophthalmic
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-477
Product ID 68083-477_e7907389-32be-4d83-a6e6-4360842d4893
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209619
Listing Expiration 2026-12-31
Marketing Start 2017-02-14

Pharmacologic Class

Classes
decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083477
Hyphenated Format 68083-477

Supplemental Identifiers

RxCUI
1111339
UPC
0368083477011
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 ophthalmic solution (source: ndc)
Generic Name olopatadine hydrochloride ophthalmic (source: ndc)
Application Number ANDA209619 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (68083-477-01) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

68083-477-01 1 BOTTLE, PLASTIC in 1 CARTON (68083-477-01) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Olopatadine Hydrochloride Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "e7907389-32be-4d83-a6e6-4360842d4893", "openfda": {"upc": ["0368083477011"], "unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["e7907389-32be-4d83-a6e6-4360842d4893"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (68083-477-01)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "68083-477-01", "marketing_start_date": "20170214"}], "brand_name": "Olopatadine Hydrochloride Ophthalmic Solution", "product_id": "68083-477_e7907389-32be-4d83-a6e6-4360842d4893", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "68083-477", "generic_name": "Olopatadine Hydrochloride Ophthalmic", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine Hydrochloride Ophthalmic Solution", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA209619", "marketing_category": "ANDA", "marketing_start_date": "20170214", "listing_expiration_date": "20261231"}