timolol maleate

Generic: timolol maleate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-313
Product ID 59651-313_a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213540
Listing Expiration 2026-12-31
Marketing Start 2023-03-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651313
Hyphenated Format 59651-313

Supplemental Identifiers

RxCUI
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 ANDA213540 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

59651-313-05 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING

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": "a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313408"], "spl_set_id": ["e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05)  / 5 mL in 1 BOTTLE, DISPENSING", "package_ndc": "59651-313-05", "marketing_start_date": "20230323"}], "brand_name": "TIMOLOL MALEATE", "product_id": "59651-313_a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "59651-313", "generic_name": "TIMOLOL MALEATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIMOLOL MALEATE", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA213540", "marketing_category": "ANDA", "marketing_start_date": "20230323", "listing_expiration_date": "20261231"}