olopatadine hydrochloride

Generic: olopatadine hydrochloride

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

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-491
Product ID 70069-491_f19c5298-b566-4416-a345-c5334c6a7ad7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215006
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

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 70069491
Hyphenated Format 70069-491

Supplemental Identifiers

RxCUI
1111343
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 ANDA215006 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 2.5 mL in 1 BOTTLE, PLASTIC (70069-491-01)
source: ndc

Packages (1)

70069-491-01 2.5 mL in 1 BOTTLE, PLASTIC (70069-491-01)

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": "f19c5298-b566-4416-a345-c5334c6a7ad7", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["6ee9f8f5-973c-4c71-8069-e76cd87b07dc"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 BOTTLE, PLASTIC (70069-491-01)", "package_ndc": "70069-491-01", "marketing_start_date": "20241220"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "70069-491_f19c5298-b566-4416-a345-c5334c6a7ad7", "dosage_form": "SOLUTION/ DROPS", "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": "70069-491", "generic_name": "Olopatadine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA215006", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}