timolol maleate

Generic: timolol maleate

Labeler: first nation group, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler first nation group, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
First Nation Group, LLC

Identifiers & Regulatory

Product NDC 81469-210
Product ID 81469-210_b666fc6c-b409-45a6-a890-fa5b41585390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078771
Listing Expiration 2026-12-31
Marketing Start 2024-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81469210
Hyphenated Format 81469-210

Supplemental Identifiers

RxCUI
1923428 1992303
UPC
0381469210057 0381469210101 0381469209105 0381469209051
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 ANDA078771 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

81469-210-05 1 BOTTLE, DROPPER in 1 CARTON (81469-210-05) / 5 mL in 1 BOTTLE, DROPPER 81469-210-10 1 BOTTLE, DROPPER in 1 CARTON (81469-210-10) / 10 mL in 1 BOTTLE, DROPPER

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": "b666fc6c-b409-45a6-a890-fa5b41585390", "openfda": {"upc": ["0381469210057", "0381469210101", "0381469209105", "0381469209051"], "unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["140e1bfc-b75e-40d1-856c-242be4d9c8cc"], "manufacturer_name": ["First Nation Group, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (81469-210-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "81469-210-05", "marketing_start_date": "20240510"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (81469-210-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "81469-210-10", "marketing_start_date": "20240510"}], "brand_name": "timolol maleate", "product_id": "81469-210_b666fc6c-b409-45a6-a890-fa5b41585390", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "81469-210", "generic_name": "timolol maleate", "labeler_name": "First Nation Group, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "timolol maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA078771", "marketing_category": "ANDA", "marketing_start_date": "20240510", "listing_expiration_date": "20261231"}