timolol hemihydrate

Generic: timolol hemihydrate

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

Drug Facts

Product Profile

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

timolol maleate 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-516
Product ID 70069-516_71408752-090e-4566-9cdf-7e0074200d3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216653
Listing Expiration 2026-12-31
Marketing Start 2024-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069516
Hyphenated Format 70069-516

Supplemental Identifiers

RxCUI
1992299
UPC
0370069517017 0370069516010
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 hemihydrate (source: ndc)
Generic Name timolol hemihydrate (source: ndc)
Application Number ANDA216653 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-516-01) / 2.5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-516-01 1 BOTTLE in 1 CARTON (70069-516-01) / 2.5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Timolol hemihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "71408752-090e-4566-9cdf-7e0074200d3a", "openfda": {"upc": ["0370069517017", "0370069516010"], "unii": ["P8Y54F701R"], "rxcui": ["1992299"], "spl_set_id": ["bfd95433-e47a-4c5c-9bdf-77bffc13544d"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-516-01)  / 2.5 mL in 1 BOTTLE", "package_ndc": "70069-516-01", "marketing_start_date": "20240709"}], "brand_name": "Timolol hemihydrate", "product_id": "70069-516_71408752-090e-4566-9cdf-7e0074200d3a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-516", "generic_name": "Timolol hemihydrate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol hemihydrate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA216653", "marketing_category": "ANDA", "marketing_start_date": "20240709", "listing_expiration_date": "20261231"}