NDC 0023-9211

COMBIGAN

Brimonidine Tartrate, Timolol Maleate

COMBIGAN is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Brimonidine Tartrate; Timolol Maleate.

• Product ID: 0023-9211_64b8e24b-15cb-4afa-8bd4-7c59e9a88da5
• NDC: 0023-9211
• Product Type: Human Prescription Drug
• Proprietary Name: COMBIGAN
• Generic Name: Brimonidine Tartrate, Timolol Maleate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2007-11-14
• Marketing Category: NDA / NDA
• Application Number: NDA021398
• Labeler Name: Allergan, Inc.
• Substance Name: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
• Active Ingredient Strength: 2 mg/mL; mg/mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0023-9211-03

1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) > 2.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2007-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-9211-15 [00023921115]

COMBIGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-11-14

NDC 0023-9211-05 [00023921105]

COMBIGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-11-14

NDC 0023-9211-03 [00023921103]

COMBIGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021398
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-11-14

NDC 0023-9211-10 [00023921110]

COMBIGAN SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-11-14

Drug Details

Active Ingredients

Ingredient	Strength
BRIMONIDINE TARTRATE	2 mg/mL

OpenFDA Data

• SPL SET ID: feaf1480-a4b8-4486-992a-96be3a596243
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4S9CL2DY2H
  • P8Y54F701R
• RxNorm Concept Unique ID - RxCUI:
  • 861635
  • 861637
• UPC Code:
  • 0300239211056

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• Adrenergic beta-Antagonists [MoA]
• beta-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "COMBIGAN" or generic name "Brimonidine Tartrate, Timolol Maleate"

NDC	Brand Name	Generic Name
0023-9211	COMBIGAN	brimonidine tartrate, timolol maleate
82182-455	BRIMONIDINE TARTRATE and TIMOLOL MALEATE	BRIMONIDINE TARTRATE, TIMOLOL MALEATE
60505-6225	Brimonidine Tartrate/Timolol Maleate	brimonidine tartrate, timolol maleate