timolol maleate

Generic: timolol maleate

Labeler: pacific pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler pacific pharma, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Pacific Pharma, Inc.

Identifiers & Regulatory

Product NDC 60758-801
Product ID 60758-801_4e61d8cb-67a4-436b-bc07-f84a7a617019
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074747
Listing Expiration 2026-12-31
Marketing Start 1997-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60758801
Hyphenated Format 60758-801

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 ANDA074747 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60758-801-05 1 BOTTLE, DROPPER in 1 CARTON (60758-801-05) / 5 mL in 1 BOTTLE, DROPPER 60758-801-10 1 BOTTLE, DROPPER in 1 CARTON (60758-801-10) / 10 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": "4e61d8cb-67a4-436b-bc07-f84a7a617019", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["e16c33fd-aa86-49ad-a767-c79ade4a62c7"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-801-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-801-05", "marketing_start_date": "19970520"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-801-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-801-10", "marketing_start_date": "19970520"}], "brand_name": "TIMOLOL MALEATE", "product_id": "60758-801_4e61d8cb-67a4-436b-bc07-f84a7a617019", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "60758-801", "generic_name": "timolol maleate", "labeler_name": "Pacific Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIMOLOL MALEATE", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA074747", "marketing_category": "ANDA", "marketing_start_date": "19970520", "listing_expiration_date": "20261231"}