olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: allwell health inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler allwell health inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
Allwell Health Inc

Identifiers & Regulatory

Product NDC 80539-001
Product ID 80539-001_12d48ef6-ccf1-4bc3-8469-0061bb083f7c
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 inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80539001
Hyphenated Format 80539-001

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 ANDA209995 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (80539-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

80539-001-39 1 BOTTLE, PLASTIC in 1 CARTON (80539-001-39) / 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": "12d48ef6-ccf1-4bc3-8469-0061bb083f7c", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["12d48ef6-ccf1-4bc3-8469-0061bb083f7c"], "manufacturer_name": ["Allwell Health Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (80539-001-39)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "80539-001-39", "marketing_start_date": "20200715"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "80539-001_12d48ef6-ccf1-4bc3-8469-0061bb083f7c", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "80539-001", "generic_name": "OLOPATADINE HYDROCHLORIDE", "labeler_name": "Allwell Health Inc", "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"}