timolol maleate

Generic: timolol maleate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-227
Product ID 61314-227_d1f4cdca-5a1b-4eb3-8b00-fa7d778bb1c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074262
Listing Expiration 2026-12-31
Marketing Start 1996-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314227
Hyphenated Format 61314-227

Supplemental Identifiers

RxCUI
1923428 1992303
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 ANDA074262 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (61314-227-05)
  • 10 mL in 1 BOTTLE, PLASTIC (61314-227-10)
  • 15 mL in 1 BOTTLE, PLASTIC (61314-227-15)
source: ndc

Packages (3)

61314-227-05 5 mL in 1 BOTTLE, PLASTIC (61314-227-05) 61314-227-10 10 mL in 1 BOTTLE, PLASTIC (61314-227-10) 61314-227-15 15 mL in 1 BOTTLE, PLASTIC (61314-227-15)

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": "d1f4cdca-5a1b-4eb3-8b00-fa7d778bb1c0", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (61314-227-05)", "package_ndc": "61314-227-05", "marketing_start_date": "19960115"}, {"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (61314-227-10)", "package_ndc": "61314-227-10", "marketing_start_date": "19960115"}, {"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (61314-227-15)", "package_ndc": "61314-227-15", "marketing_start_date": "19960115"}], "brand_name": "Timolol Maleate", "product_id": "61314-227_d1f4cdca-5a1b-4eb3-8b00-fa7d778bb1c0", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "61314-227", "generic_name": "Timolol Maleate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA074262", "marketing_category": "ANDA", "marketing_start_date": "19960115", "listing_expiration_date": "20261231"}