olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler alembic pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-502
Product ID 62332-502_fb3ef8a7-46e3-4d8e-83df-117674d1c8aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209420
Listing Expiration 2026-12-31
Marketing Start 2019-04-29

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 62332502
Hyphenated Format 62332-502

Supplemental Identifiers

RxCUI
1111343
UPC
0362332502035
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 ANDA209420 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (62332-502-03) / 2.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

62332-502-03 1 BOTTLE, PLASTIC in 1 CARTON (62332-502-03) / 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": "fb3ef8a7-46e3-4d8e-83df-117674d1c8aa", "openfda": {"upc": ["0362332502035"], "unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["dbcdf10c-5adb-4d48-97ce-f4b82c6bc77d"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (62332-502-03)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "62332-502-03", "marketing_start_date": "20190429"}], "brand_name": "OLOPATADINE HYDROCHLORIDE", "product_id": "62332-502_fb3ef8a7-46e3-4d8e-83df-117674d1c8aa", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "62332-502", "generic_name": "olopatadine hydrochloride", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLOPATADINE HYDROCHLORIDE", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA209420", "marketing_category": "ANDA", "marketing_start_date": "20190429", "listing_expiration_date": "20261231"}