timolol maleate

Generic: timolol maleate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler sagent pharmaceuticals
Dosage Form SOLUTION, GEL FORMING / DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 2.5 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-008
Product ID 25021-008_ff0af07d-608a-44c6-936a-f22e726d3f41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214645
Listing Expiration 2027-12-31
Marketing Start 2026-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021008
Hyphenated Format 25021-008

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 maleate (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number ANDA214645 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

25021-008-05 1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (2.5 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": "ff0af07d-608a-44c6-936a-f22e726d3f41", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["272bb565-f099-4896-b2f6-48ab9180e941"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25021-008-05)  / 5 mL in 1 BOTTLE", "package_ndc": "25021-008-05", "marketing_start_date": "20260115"}], "brand_name": "Timolol Maleate", "product_id": "25021-008_ff0af07d-608a-44c6-936a-f22e726d3f41", "dosage_form": "SOLUTION, GEL FORMING / DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "25021-008", "generic_name": "Timolol Maleate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "2.5 mg/mL"}], "application_number": "ANDA214645", "marketing_category": "ANDA", "marketing_start_date": "20260115", "listing_expiration_date": "20271231"}