timolol maleate

Generic: timolol maleate

Labeler: armas pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler armas pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 6.8 mg/mL

Manufacturer
Armas Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72485-602
Product ID 72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217195
Listing Expiration 2026-12-31
Marketing Start 2023-05-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485602
Hyphenated Format 72485-602

Supplemental Identifiers

RxCUI
1922894
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 ANDA217195 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 6.8 mg/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (72485-602-60) / 10 VIAL in 1 POUCH (72485-602-05) / .3 mL in 1 VIAL
source: ndc

Packages (1)

72485-602-60 6 POUCH in 1 CARTON (72485-602-60) / 10 VIAL in 1 POUCH (72485-602-05) / .3 mL in 1 VIAL

Ingredients (1)

timolol maleate (6.8 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": "9173b81c-8ae8-4b3b-a0b8-2530a1462616", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1922894"], "spl_set_id": ["ea585fe8-3356-4f08-8078-34e8ab5de37e"], "manufacturer_name": ["Armas Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (72485-602-60)  / 10 VIAL in 1 POUCH (72485-602-05)  / .3 mL in 1 VIAL", "package_ndc": "72485-602-60", "marketing_start_date": "20230508"}], "brand_name": "Timolol maleate", "product_id": "72485-602_9173b81c-8ae8-4b3b-a0b8-2530a1462616", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72485-602", "generic_name": "Timolol maleate", "labeler_name": "Armas Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "6.8 mg/mL"}], "application_number": "ANDA217195", "marketing_category": "ANDA", "marketing_start_date": "20230508", "listing_expiration_date": "20261231"}