olopatadine hydrochloride ophthalmic solution twice daily

Generic: olopatadine hydrochloride ophthalmic

Labeler: dolgencorp, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride ophthalmic solution twice daily
Generic Name olopatadine hydrochloride ophthalmic
Labeler dolgencorp, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
DOLGENCORP, LLC

Identifiers & Regulatory

Product NDC 55910-109
Product ID 55910-109_fb7ff287-49de-f4ae-11fd-1b7726814156
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209619
Listing Expiration 2026-12-31
Marketing Start 2021-12-01

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 55910109
Hyphenated Format 55910-109

Supplemental Identifiers

RxCUI
1111339
UNII
2XG66W44KF

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 twice daily (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 (55910-109-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

55910-109-05 1 BOTTLE, PLASTIC in 1 CARTON (55910-109-05) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Olopatadine Hydrochloride Ophthalmic Solution Twice Daily ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "fb7ff287-49de-f4ae-11fd-1b7726814156", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["a9f03242-b5fa-5762-f9a6-b7c0c5ee46c3"], "manufacturer_name": ["DOLGENCORP, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (55910-109-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "55910-109-05", "marketing_start_date": "20211201"}], "brand_name": "Olopatadine Hydrochloride Ophthalmic Solution Twice Daily", "product_id": "55910-109_fb7ff287-49de-f4ae-11fd-1b7726814156", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "55910-109", "generic_name": "Olopatadine Hydrochloride Ophthalmic", "labeler_name": "DOLGENCORP, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine Hydrochloride Ophthalmic Solution", "brand_name_suffix": "Twice Daily", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA209619", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}