brimonidine tartrate

Generic: brimonidine tartrate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate
Generic Name brimonidine tartrate
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 1.5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0564
Product ID 60505-0564_5832760f-7397-35f8-6aa8-abdaebbe657a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078479
Listing Expiration 2026-12-31
Marketing Start 2022-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050564
Hyphenated Format 60505-0564

Supplemental Identifiers

RxCUI
861208
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 ANDA078479 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

60505-0564-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER 60505-0564-2 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2) / 10 mL in 1 BOTTLE, DROPPER 60505-0564-3 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

brimonidine tartrate (1.5 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": "5832760f-7397-35f8-6aa8-abdaebbe657a", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["861208"], "spl_set_id": ["64b21e68-610c-5194-ccb2-9d9f6ff8cda9"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0564-1", "marketing_start_date": "20220131"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0564-2", "marketing_start_date": "20220314"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0564-3", "marketing_start_date": "20220131"}], "brand_name": "Brimonidine Tartrate", "product_id": "60505-0564_5832760f-7397-35f8-6aa8-abdaebbe657a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "60505-0564", "generic_name": "brimonidine tartrate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine Tartrate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "1.5 mg/mL"}], "application_number": "ANDA078479", "marketing_category": "ANDA", "marketing_start_date": "20220131", "listing_expiration_date": "20261231"}