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 SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 2.5 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-513
Product ID 64980-513_7ef88352-6fe4-48a4-b72b-15419d3ed051
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077259
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980513
Hyphenated Format 64980-513

Supplemental Identifiers

RxCUI
1923428 1992303
UPC
0364980513050 0364980514057
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 ANDA077259 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64980-513-01) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (64980-513-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (64980-513-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

64980-513-01 1 BOTTLE in 1 CARTON (64980-513-01) / 10 mL in 1 BOTTLE 64980-513-05 1 BOTTLE in 1 CARTON (64980-513-05) / 5 mL in 1 BOTTLE 64980-513-15 1 BOTTLE in 1 CARTON (64980-513-15) / 15 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (2.5 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": "7ef88352-6fe4-48a4-b72b-15419d3ed051", "openfda": {"upc": ["0364980513050", "0364980514057"], "unii": ["P8Y54F701R"], "rxcui": ["1923428", "1992303"], "spl_set_id": ["2ed21930-1e05-46de-8acd-cb6f4798a7fa"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-513-01)  / 10 mL in 1 BOTTLE", "package_ndc": "64980-513-01", "marketing_start_date": "20141215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-513-05)  / 5 mL in 1 BOTTLE", "package_ndc": "64980-513-05", "marketing_start_date": "20141215"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (64980-513-15)  / 15 mL in 1 BOTTLE", "package_ndc": "64980-513-15", "marketing_start_date": "20141215"}], "brand_name": "TIMOLOL MALEATE", "product_id": "64980-513_7ef88352-6fe4-48a4-b72b-15419d3ed051", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "64980-513", "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": "2.5 mg/mL"}], "application_number": "ANDA077259", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}