timolol gfs

Generic: timolol maleate

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

Drug Facts

Product Profile

Brand Name timolol gfs
Generic Name timolol maleate
Labeler sandoz inc
Dosage Form SOLUTION, GEL FORMING / DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 2.5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-224
Product ID 61314-224_ba538348-67cf-4031-84e5-cb84647af104
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020963
Listing Expiration 2026-12-31
Marketing Start 1998-12-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314224
Hyphenated Format 61314-224

Supplemental Identifiers

RxCUI
313407 313408
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 gfs (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number NDA020963 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (61314-224-05)
  • 2.5 mL in 1 BOTTLE (61314-224-25)
source: ndc

Packages (2)

61314-224-05 5 mL in 1 BOTTLE (61314-224-05) 61314-224-25 2.5 mL in 1 BOTTLE (61314-224-25)

Ingredients (1)

timolol maleate (2.5 mg/mL)

Linked Drug Pages (1)

Timolol GFS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "ba538348-67cf-4031-84e5-cb84647af104", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["72b0d0ec-832a-4c25-b845-2537ab506354"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (61314-224-05)", "package_ndc": "61314-224-05", "marketing_start_date": "19981224"}, {"sample": false, "description": "2.5 mL in 1 BOTTLE (61314-224-25)", "package_ndc": "61314-224-25", "marketing_start_date": "19981224"}], "brand_name": "Timolol GFS", "product_id": "61314-224_ba538348-67cf-4031-84e5-cb84647af104", "dosage_form": "SOLUTION, GEL FORMING / DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "61314-224", "generic_name": "timolol maleate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol GFS", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "2.5 mg/mL"}], "application_number": "NDA020963", "marketing_category": "NDA", "marketing_start_date": "19981224", "listing_expiration_date": "20261231"}