timolol maleate

Generic: timolol maleate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

timolol maleate 2.5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-701
Product ID 70069-701_e37dc12f-1930-43d0-87a5-ae1eebff29f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217764
Listing Expiration 2026-12-31
Marketing Start 2024-07-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069701
Hyphenated Format 70069-701

Supplemental Identifiers

RxCUI
1923428 1992303
UPC
0370069706015 0370069703014 0370069708019 0370069701010 0370069702017 0370069707012
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 ANDA217764 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-701-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-701-01 1 BOTTLE in 1 CARTON (70069-701-01) / 5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (2.5 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": "e37dc12f-1930-43d0-87a5-ae1eebff29f6", "openfda": {"upc": ["0370069706015", "0370069703014", "0370069708019", "0370069701010", "0370069702017", "0370069707012"], "unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["5d60db57-ca24-4cab-a90d-8cf06992a34e"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-701-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70069-701-01", "marketing_start_date": "20240704"}], "brand_name": "Timolol maleate", "product_id": "70069-701_e37dc12f-1930-43d0-87a5-ae1eebff29f6", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-701", "generic_name": "Timolol maleate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "2.5 mg/mL"}], "application_number": "ANDA217764", "marketing_category": "ANDA", "marketing_start_date": "20240704", "listing_expiration_date": "20261231"}