brimonidine tartrate/timolol maleate

Generic: brimonidine tartrate and timolol maleate

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

Drug Facts

Product Profile

Brand Name brimonidine tartrate/timolol maleate
Generic Name brimonidine tartrate and timolol maleate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 2 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-281
Product ID 68462-281_ee811db1-4206-4e8c-a9db-daf45b63f900
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214987
Listing Expiration 2027-12-31
Marketing Start 2024-05-16

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] adrenergic beta-antagonists [moa] alpha-adrenergic agonist [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462281
Hyphenated Format 68462-281

Supplemental Identifiers

RxCUI
861635
UPC
0368462281697
UNII
4S9CL2DY2H 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 brimonidine tartrate/timolol maleate (source: ndc)
Generic Name brimonidine tartrate and timolol maleate (source: ndc)
Application Number ANDA214987 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

68462-281-32 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER 68462-281-69 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (2)

brimonidine tartrate (2 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Brimonidine Tartrate/Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "ee811db1-4206-4e8c-a9db-daf45b63f900", "openfda": {"upc": ["0368462281697"], "unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["bf6a7f59-5a10-49fe-9e57-19e3ba202918"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68462-281-32)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "68462-281-32", "marketing_start_date": "20240516"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68462-281-69)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68462-281-69", "marketing_start_date": "20240516"}], "brand_name": "Brimonidine Tartrate/Timolol Maleate", "product_id": "68462-281_ee811db1-4206-4e8c-a9db-daf45b63f900", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68462-281", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate/Timolol Maleate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA214987", "marketing_category": "ANDA", "marketing_start_date": "20240516", "listing_expiration_date": "20271231"}