timolol maleate

Generic: timolol maleate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler northstar rxllc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-540
Product ID 72603-540_1226c91d-666c-4d6a-9af3-7f12efe1a15f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078771
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603540
Hyphenated Format 72603-540

Supplemental Identifiers

RxCUI
1992303
UPC
0372603540017
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 ANDA078771 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

72603-540-01 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 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": "1226c91d-666c-4d6a-9af3-7f12efe1a15f", "openfda": {"upc": ["0372603540017"], "unii": ["P8Y54F701R"], "rxcui": ["1992303"], "spl_set_id": ["9db7322d-eb31-4fff-9b14-8a0294d01704"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72603-540-01)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72603-540-01", "marketing_start_date": "20241201"}], "brand_name": "timolol maleate", "product_id": "72603-540_1226c91d-666c-4d6a-9af3-7f12efe1a15f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72603-540", "generic_name": "timolol maleate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "timolol maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA078771", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}