timolol maleate ophthalmic gel forming solution 0.25%

Generic: timolol maleate ophthalmic gel forming solution 0.25%

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

Drug Facts

Product Profile

Brand Name timolol maleate ophthalmic gel forming solution 0.25%
Generic Name timolol maleate ophthalmic gel forming solution 0.25%
Labeler northstar rxllc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 2.5 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-162
Product ID 72603-162_1e9cae2e-e3bf-9a9d-22cc-c4a037e47409
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215733
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603162
Hyphenated Format 72603-162

Supplemental Identifiers

RxCUI
313407 313408
UPC
0372603162011
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 ophthalmic gel forming solution 0.25% (source: ndc)
Generic Name timolol maleate ophthalmic gel forming solution 0.25% (source: ndc)
Application Number ANDA215733 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72603-162-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

72603-162-01 1 BOTTLE in 1 CARTON (72603-162-01) / 5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (2.5 mg/mL)

Linked Drug Pages (1)

Timolol Maleate Ophthalmic Gel Forming Solution 0.25%, Timolol Maleate Ophthalmic Gel Forming Solution 0.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1e9cae2e-e3bf-9a9d-22cc-c4a037e47409", "openfda": {"upc": ["0372603162011"], "unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["9515f95c-e29b-3c7f-0bdd-cda783988a72"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-162-01)  / 5 mL in 1 BOTTLE", "package_ndc": "72603-162-01", "marketing_start_date": "20230814"}], "brand_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.25%", "product_id": "72603-162_1e9cae2e-e3bf-9a9d-22cc-c4a037e47409", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72603-162", "generic_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.25%", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate Ophthalmic Gel Forming Solution 0.25%", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "2.5 mg/mL"}], "application_number": "ANDA215733", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}