timolol maleate

Generic: timolol maleate

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler oceanside pharmaceuticals
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-045
Product ID 68682-045_9ec6544e-8fd7-4541-ab00-f8fa87227d9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021516
Listing Expiration 2026-12-31
Marketing Start 2018-05-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682045
Hyphenated Format 68682-045

Supplemental Identifiers

RxCUI
1992299
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 NDA021516 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (68682-045-50) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

68682-045-25 1 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER 68682-045-50 1 BOTTLE, DROPPER in 1 CARTON (68682-045-50) / 5 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": "9ec6544e-8fd7-4541-ab00-f8fa87227d9c", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1992299"], "spl_set_id": ["3c20b537-88c6-4ec7-a359-e0ba67afe431"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68682-045-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68682-045-25", "marketing_start_date": "20180530"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68682-045-50)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68682-045-50", "marketing_start_date": "20180530"}], "brand_name": "Timolol Maleate", "product_id": "68682-045_9ec6544e-8fd7-4541-ab00-f8fa87227d9c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68682-045", "generic_name": "Timolol Maleate", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA021516", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180530", "listing_expiration_date": "20261231"}