brimonidine tartrate

Generic: brimonidine tartrate

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

brimonidine tartrate 2 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-419
Product ID 42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217846
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571419
Hyphenated Format 42571-419

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 ANDA217846 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

42571-419-56 1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPER 42571-419-57 1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPER 42571-419-92 1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

brimonidine tartrate (2 mg/mL)

Linked Drug Pages (1)

Brimonidine tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3aac4288-aa47-296b-e063-6294a90a8fd8", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["861200"], "spl_set_id": ["75c5f708-1afb-4505-94a6-a2c0afb0aedc"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (42571-419-56)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "42571-419-56", "marketing_start_date": "20240401"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (42571-419-57)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "42571-419-57", "marketing_start_date": "20240401"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (42571-419-92)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "42571-419-92", "marketing_start_date": "20240401"}], "brand_name": "Brimonidine tartrate", "product_id": "42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "42571-419", "generic_name": "Brimonidine tartrate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine tartrate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}], "application_number": "ANDA217846", "marketing_category": "ANDA", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}