brimonidine tartrate and timolol maleate

Generic: brimonidine tartrate and timolol maleate

Labeler: sandoz inc
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 sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-7186
Product ID 0781-7186_936fadf8-8b5d-48cf-a875-0fe182a9d41a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091087
Listing Expiration 2026-12-31
Marketing Start 2022-04-13

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 07817186
Hyphenated Format 0781-7186

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 ANDA091087 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0781-7186-70) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0781-7186-75) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0781-7186-85) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

0781-7186-70 1 BOTTLE in 1 CARTON (0781-7186-70) / 10 mL in 1 BOTTLE 0781-7186-75 1 BOTTLE in 1 CARTON (0781-7186-75) / 5 mL in 1 BOTTLE 0781-7186-85 1 BOTTLE in 1 CARTON (0781-7186-85) / 15 mL in 1 BOTTLE

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": "936fadf8-8b5d-48cf-a875-0fe182a9d41a", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["af21d2e5-0029-4889-ba93-6417baa91ce6"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0781-7186-70)  / 10 mL in 1 BOTTLE", "package_ndc": "0781-7186-70", "marketing_start_date": "20220413"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0781-7186-75)  / 5 mL in 1 BOTTLE", "package_ndc": "0781-7186-75", "marketing_start_date": "20220413"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0781-7186-85)  / 15 mL in 1 BOTTLE", "package_ndc": "0781-7186-85", "marketing_start_date": "20220413"}], "brand_name": "Brimonidine Tartrate and Timolol Maleate", "product_id": "0781-7186_936fadf8-8b5d-48cf-a875-0fe182a9d41a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0781-7186", "generic_name": "Brimonidine Tartrate and Timolol Maleate", "labeler_name": "Sandoz Inc", "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": "ANDA091087", "marketing_category": "ANDA", "marketing_start_date": "20220413", "listing_expiration_date": "20261231"}