timolol maleate

Generic: timolol maleate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler caplin steriles limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-152
Product ID 65145-152_4847f180-45e6-40f0-ae8c-6cc500cb0add
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218460
Listing Expiration 2026-12-31
Marketing Start 2024-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145152
Hyphenated Format 65145-152

Supplemental Identifiers

RxCUI
1992303
UPC
0365145153012 0365145152015 0365145154019
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
  • 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

65145-152-01 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE

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": "4847f180-45e6-40f0-ae8c-6cc500cb0add", "openfda": {"upc": ["0365145153012", "0365145152015", "0365145154019"], "unii": ["P8Y54F701R"], "rxcui": ["1992303"], "spl_set_id": ["4847f180-45e6-40f0-ae8c-6cc500cb0add"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65145-152-01)  / 5 mL in 1 BOTTLE", "package_ndc": "65145-152-01", "marketing_start_date": "20240916"}], "brand_name": "Timolol Maleate", "product_id": "65145-152_4847f180-45e6-40f0-ae8c-6cc500cb0add", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "65145-152", "generic_name": "Timolol Maleate", "labeler_name": "Caplin Steriles Limited", "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": "20240916", "listing_expiration_date": "20261231"}