combigan

Generic: brimonidine tartrate, timolol maleate

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name combigan
Generic Name brimonidine tartrate, timolol maleate
Labeler allergan, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-9211
Product ID 0023-9211_b31201db-b90e-4f4c-980f-0a206e63e36c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021398
Listing Expiration 2026-12-31
Marketing Start 2007-11-14

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 00239211
Hyphenated Format 0023-9211

Supplemental Identifiers

RxCUI
861635 861637
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 combigan (source: ndc)
Generic Name brimonidine tartrate, timolol maleate (source: ndc)
Application Number NDA021398 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (4)

0023-9211-03 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) / 2.5 mL in 1 BOTTLE, DROPPER 0023-9211-05 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) / 5 mL in 1 BOTTLE, DROPPER 0023-9211-10 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-10) / 10 mL in 1 BOTTLE, DROPPER 0023-9211-15 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

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

Linked Drug Pages (1)

COMBIGAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b31201db-b90e-4f4c-980f-0a206e63e36c", "openfda": {"unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635", "861637"], "spl_set_id": ["feaf1480-a4b8-4486-992a-96be3a596243"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-9211-03", "marketing_start_date": "20071114"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-9211-05", "marketing_start_date": "20071114"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-9211-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-9211-10", "marketing_start_date": "20071114"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0023-9211-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0023-9211-15", "marketing_start_date": "20071114"}], "brand_name": "COMBIGAN", "product_id": "0023-9211_b31201db-b90e-4f4c-980f-0a206e63e36c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0023-9211", "generic_name": "brimonidine tartrate, timolol maleate", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COMBIGAN", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA021398", "marketing_category": "NDA", "marketing_start_date": "20071114", "listing_expiration_date": "20261231"}