timolol maleate

Generic: timolol maleate

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

Drug Facts

Product Profile

Brand Name timolol maleate
Generic Name timolol maleate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

timolol maleate 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0221
Product ID 0378-0221_30d62085-4192-46af-b05a-da3eed7d1fc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072668
Marketing Start 1990-06-08
Marketing End 2027-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780221
Hyphenated Format 0378-0221

Supplemental Identifiers

RxCUI
198284 198285 198286
UPC
0303780055018
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 ANDA072668 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)
source: ndc

Packages (1)

0378-0221-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)

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": "30d62085-4192-46af-b05a-da3eed7d1fc5", "openfda": {"upc": ["0303780055018"], "unii": ["P8Y54F701R"], "rxcui": ["198284", "198285", "198286"], "spl_set_id": ["57c62928-63d8-4505-9b9e-c085a3a12c95"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)", "package_ndc": "0378-0221-01", "marketing_end_date": "20270331", "marketing_start_date": "19900608"}], "brand_name": "Timolol Maleate", "product_id": "0378-0221_30d62085-4192-46af-b05a-da3eed7d1fc5", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0378-0221", "generic_name": "timolol maleate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA072668", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "19900608"}