timolol maleate

Generic: timolol maleate

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler ingenus pharmaceuticals, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 3.4 mg/mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-287
Product ID 50742-287_a6586769-4fb8-41df-bfd6-0971090ab79b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216533
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742287
Hyphenated Format 50742-287

Supplemental Identifiers

RxCUI
1922876 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 ANDA216533 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3.4 mg/mL
source: ndc
Packaging
  • 15 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER
source: ndc

Packages (1)

50742-287-60 15 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER

Ingredients (1)

timolol maleate (3.4 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": "a6586769-4fb8-41df-bfd6-0971090ab79b", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1922876", "1922894"], "spl_set_id": ["4c4318b3-9865-4172-a7bd-9e68913eca1e"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 POUCH in 1 CARTON (50742-287-60)  / 4 CONTAINER in 1 POUCH (50742-287-04)  / .3 mL in 1 CONTAINER", "package_ndc": "50742-287-60", "marketing_start_date": "20220915"}], "brand_name": "Timolol Maleate", "product_id": "50742-287_a6586769-4fb8-41df-bfd6-0971090ab79b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50742-287", "generic_name": "timolol maleate", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "3.4 mg/mL"}], "application_number": "ANDA216533", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}