brimonidine tartrate

Generic: brimonidine tartrate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine tartrate
Generic Name brimonidine tartrate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 1 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-568
Product ID 70069-568_5a808f88-afeb-4ab3-b005-56b68b27dc7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216906
Listing Expiration 2026-12-31
Marketing Start 2024-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069568
Hyphenated Format 70069-568

Supplemental Identifiers

RxCUI
861204
UPC
0370069566015 0370069568019 0370069567012
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 ANDA216906 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-568-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-568-01 1 BOTTLE in 1 CARTON (70069-568-01) / 15 mL in 1 BOTTLE

Ingredients (1)

brimonidine tartrate (1 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": "5a808f88-afeb-4ab3-b005-56b68b27dc7f", "openfda": {"upc": ["0370069566015", "0370069568019", "0370069567012"], "unii": ["4S9CL2DY2H"], "rxcui": ["861204"], "spl_set_id": ["b8e108b3-aca8-4e3e-8577-37ac796148c3"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-568-01)  / 15 mL in 1 BOTTLE", "package_ndc": "70069-568-01", "marketing_start_date": "20240826"}], "brand_name": "BRIMONIDINE TARTRATE", "product_id": "70069-568_5a808f88-afeb-4ab3-b005-56b68b27dc7f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70069-568", "generic_name": "BRIMONIDINE TARTRATE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BRIMONIDINE TARTRATE", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "1 mg/mL"}], "application_number": "ANDA216906", "marketing_category": "ANDA", "marketing_start_date": "20240826", "listing_expiration_date": "20261231"}