timolol maleate

Generic: timolol maleate

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-325
Product ID 69315-325_b6fecc68-5e40-4191-a365-568ccedf0697
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218460
Listing Expiration 2026-12-31
Marketing Start 2024-11-07

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315325
Hyphenated Format 69315-325

Supplemental Identifiers

RxCUI
1992303
UNII
P8Y54F701R

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 timolol maleate (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number ANDA218460 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (69315-325-05)
  • 10 mL in 1 BOTTLE, PLASTIC (69315-325-10)
  • 15 mL in 1 BOTTLE, PLASTIC (69315-325-15)
source: ndc

Packages (3)

69315-325-05 5 mL in 1 BOTTLE, PLASTIC (69315-325-05) 69315-325-10 10 mL in 1 BOTTLE, PLASTIC (69315-325-10) 69315-325-15 15 mL in 1 BOTTLE, PLASTIC (69315-325-15)

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

TIMOLOL MALEATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b6fecc68-5e40-4191-a365-568ccedf0697", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1992303"], "spl_set_id": ["d6fa2971-dacf-42ab-99bc-c7ce6013221e"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (69315-325-05)", "package_ndc": "69315-325-05", "marketing_start_date": "20241107"}, {"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (69315-325-10)", "package_ndc": "69315-325-10", "marketing_start_date": "20241107"}, {"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (69315-325-15)", "package_ndc": "69315-325-15", "marketing_start_date": "20241107"}], "brand_name": "TIMOLOL MALEATE", "product_id": "69315-325_b6fecc68-5e40-4191-a365-568ccedf0697", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "69315-325", "generic_name": "TIMOLOL MALEATE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIMOLOL MALEATE", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA218460", "marketing_category": "ANDA", "marketing_start_date": "20241107", "listing_expiration_date": "20261231"}