olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler a-s medication solutions
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5613
Product ID 50090-5613_9af6a9b4-aff1-48bd-bd0c-9cdff0c1e4f2
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 500905613
Hyphenated Format 50090-5613

Supplemental Identifiers

RxCUI
1111343
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 (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 (50090-5613-0) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50090-5613-0 1 BOTTLE, PLASTIC in 1 CARTON (50090-5613-0) / 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": "9af6a9b4-aff1-48bd-bd0c-9cdff0c1e4f2", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50090-5613-0)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50090-5613-0", "marketing_start_date": "20210813"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "50090-5613_9af6a9b4-aff1-48bd-bd0c-9cdff0c1e4f2", "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": "50090-5613", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "A-S Medication Solutions", "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"}