timolol maleate

Generic: timolol maleate ophthalmic

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate ophthalmic
Labeler micro labs limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-404
Product ID 42571-404_238fd036-1868-da83-e063-6394a90a0596
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217343
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571404
Hyphenated Format 42571-404

Supplemental Identifiers

RxCUI
1923428 1992303
UPC
0342571404215 0342571403218
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 ophthalmic (source: ndc)
Application Number ANDA217343 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (42571-404-21)
  • 10 mL in 1 BOTTLE (42571-404-88)
source: ndc

Packages (2)

42571-404-21 5 mL in 1 BOTTLE (42571-404-21) 42571-404-88 10 mL in 1 BOTTLE (42571-404-88)

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": "238fd036-1868-da83-e063-6394a90a0596", "openfda": {"upc": ["0342571404215", "0342571403218"], "unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["6c9f3971-8c07-4d3a-915d-76438baa2a0b"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (42571-404-21)", "package_ndc": "42571-404-21", "marketing_start_date": "20230801"}, {"sample": false, "description": "10 mL in 1 BOTTLE (42571-404-88)", "package_ndc": "42571-404-88", "marketing_start_date": "20230801"}], "brand_name": "Timolol Maleate", "product_id": "42571-404_238fd036-1868-da83-e063-6394a90a0596", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42571-404", "generic_name": "Timolol Maleate Ophthalmic", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA217343", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}