timolol maleate

Generic: timolol maleate

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

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

timolol maleate 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-224
Product ID 16571-224_ebb620d8-8e2e-4632-b8a8-74f41c9969e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207556
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571224
Hyphenated Format 16571-224

Supplemental Identifiers

RxCUI
198284 198285 198286
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 ANDA207556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-224-01)
source: ndc

Packages (1)

16571-224-01 100 TABLET in 1 BOTTLE (16571-224-01)

Ingredients (1)

timolol maleate (10 mg/1)

Linked Drug Pages (1)

Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ebb620d8-8e2e-4632-b8a8-74f41c9969e6", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["198284", "198285", "198286"], "spl_set_id": ["0bc40b2c-65eb-4095-87e6-4752d5b19a3a"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-224-01)", "package_ndc": "16571-224-01", "marketing_start_date": "20241210"}], "brand_name": "Timolol Maleate", "product_id": "16571-224_ebb620d8-8e2e-4632-b8a8-74f41c9969e6", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "16571-224", "generic_name": "Timolol Maleate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA207556", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}