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, GEL FORMING / DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-251
Product ID 70069-251_a7b2ec00-1f4a-4058-a397-82d028d8476c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210640
Listing Expiration 2026-12-31
Marketing Start 2024-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069251
Hyphenated Format 70069-251

Supplemental Identifiers

RxCUI
313407 313408
UPC
0370069251010 0370069241011
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 ANDA210640 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-251-01 1 BOTTLE in 1 CARTON (70069-251-01) / 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": "a7b2ec00-1f4a-4058-a397-82d028d8476c", "openfda": {"upc": ["0370069251010", "0370069241011"], "unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["e797f7c7-0588-4627-b060-8df6bcfe3f7b"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-251-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70069-251-01", "marketing_start_date": "20241031"}], "brand_name": "Timolol Maleate", "product_id": "70069-251_a7b2ec00-1f4a-4058-a397-82d028d8476c", "dosage_form": "SOLUTION, GEL FORMING / DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-251", "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": "5 mg/mL"}], "application_number": "ANDA210640", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}