brimonidine tartrate

Generic: brimonidine tartrate

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate
Generic Name brimonidine tartrate
Labeler indoco remedies limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 2 mg/mg

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-400
Product ID 14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091691
Listing Expiration 2026-12-31
Marketing Start 2015-01-01

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445400
Hyphenated Format 14445-400

Supplemental Identifiers

RxCUI
861200
UNII
4S9CL2DY2H

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 (source: ndc)
Generic Name brimonidine tartrate (source: ndc)
Application Number ANDA091691 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mg
source: ndc
Packaging
  • 5 mg in 1 BOTTLE, PLASTIC (14445-400-05)
  • 10 mg in 1 BOTTLE, PLASTIC (14445-400-10)
  • 15 mg in 1 BOTTLE, PLASTIC (14445-400-15)
source: ndc

Packages (3)

14445-400-05 5 mg in 1 BOTTLE, PLASTIC (14445-400-05) 14445-400-10 10 mg in 1 BOTTLE, PLASTIC (14445-400-10) 14445-400-15 15 mg in 1 BOTTLE, PLASTIC (14445-400-15)

Ingredients (1)

brimonidine tartrate (2 mg/mg)

Linked Drug Pages (1)

Brimonidine Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "383421a5-5d33-4f15-88f4-8b66fcbfac71", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["861200"], "spl_set_id": ["383421a5-5d33-4f15-88f4-8b66fcbfac71"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mg in 1 BOTTLE, PLASTIC (14445-400-05)", "package_ndc": "14445-400-05", "marketing_start_date": "20150101"}, {"sample": false, "description": "10 mg in 1 BOTTLE, PLASTIC (14445-400-10)", "package_ndc": "14445-400-10", "marketing_start_date": "20150101"}, {"sample": false, "description": "15 mg in 1 BOTTLE, PLASTIC (14445-400-15)", "package_ndc": "14445-400-15", "marketing_start_date": "20150101"}], "brand_name": "Brimonidine Tartrate", "product_id": "14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "14445-400", "generic_name": "Brimonidine Tartrate", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mg"}], "application_number": "ANDA091691", "marketing_category": "ANDA", "marketing_start_date": "20150101", "listing_expiration_date": "20261231"}