timolol maleate

Generic: timolol maleate

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

Drug Facts

Product Profile

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

timolol maleate 6.8 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-398
Product ID 42571-398_2882b434-4502-6a6e-e063-6394a90af575
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216596
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571398
Hyphenated Format 42571-398

Supplemental Identifiers

RxCUI
1922894
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 ANDA216596 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 6.8 mg/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL
source: ndc

Packages (1)

42571-398-71 6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL

Ingredients (1)

timolol maleate (6.8 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": "2882b434-4502-6a6e-e063-6394a90af575", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1922894"], "spl_set_id": ["79b223e4-d929-4667-8149-e79bfab13fdf"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (42571-398-71)  / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL", "package_ndc": "42571-398-71", "marketing_start_date": "20230101"}], "brand_name": "Timolol Maleate", "product_id": "42571-398_2882b434-4502-6a6e-e063-6394a90af575", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42571-398", "generic_name": "Timolol Maleate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "6.8 mg/mL"}], "application_number": "ANDA216596", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}