brimonidine tartrate and timolol maleate

Generic: brimonidine tartrate and timolol maleate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate and timolol maleate
Generic Name brimonidine tartrate and timolol maleate
Labeler upsher-smith laboratories, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1425
Product ID 0832-1425_26693226-0059-2890-e063-6394a90abf9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215598
Listing Expiration 2026-12-31
Marketing Start 2022-12-15

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 08321425
Hyphenated Format 0832-1425

Supplemental Identifiers

RxCUI
861635
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 and timolol maleate (source: ndc)
Generic Name brimonidine tartrate and timolol maleate (source: ndc)
Application Number ANDA215598 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

0832-1425-05 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER 0832-1425-10 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER 0832-1425-15 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

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

Linked Drug Pages (1)

Brimonidine Tartrate and Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "26693226-0059-2890-e063-6394a90abf9a", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["b54e5bee-2329-4cc2-bed1-8eef11ee488c"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0832-1425-05", "marketing_start_date": "20230109"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0832-1425-10", "marketing_start_date": "20230109"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0832-1425-15", "marketing_start_date": "20231020"}], "brand_name": "Brimonidine Tartrate and Timolol Maleate", "product_id": "0832-1425_26693226-0059-2890-e063-6394a90abf9a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0832-1425", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate and Timolol Maleate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA215598", "marketing_category": "ANDA", "marketing_start_date": "20221215", "listing_expiration_date": "20261231"}