brimonidine tartrate and timolol maleate (71921-188)

Drug Facts

Product Profile

Brand Name brimonidine tartrate and timolol maleate

Generic Name brimonidine tartrate and timolol maleate

Labeler florida pharmaceutical products, llc

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

brimonidine tartrate 2 mg/mL, timolol maleate 5 mg/mL

Manufacturer

Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-188

Product ID 71921-188_0b25c3d0-6cf7-cce0-e063-6294a90a8ea9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201949

Listing Expiration 2026-12-31

Marketing Start 2023-11-23

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] adrenergic beta-antagonists [moa] alpha-adrenergic agonist [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921188

Hyphenated Format 71921-188

Supplemental Identifiers

RxCUI

861635

UPC

0371921188109

UNII

4S9CL2DY2H P8Y54F701R

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 and timolol maleate (source: ndc)

Generic Name brimonidine tartrate and timolol maleate (source: ndc)

Application Number ANDA201949 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

2 mg/mL
5 mg/mL

source: ndc

Packaging

1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER
1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER

source: ndc

Packages (3)

71921-188-05 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER 71921-188-10 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER 71921-188-15 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (2)

brimonidine tartrate (2 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Brimonidine tartrate and Timolol maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "0b25c3d0-6cf7-cce0-e063-6294a90a8ea9", "openfda": {"upc": ["0371921188109"], "unii": ["4S9CL2DY2H", "P8Y54F701R"], "rxcui": ["861635"], "spl_set_id": ["7011a203-46cf-434d-ba11-253f107ff80f"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (71921-188-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "71921-188-05", "marketing_start_date": "20231123"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (71921-188-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "71921-188-10", "marketing_start_date": "20231123"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (71921-188-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "71921-188-15", "marketing_start_date": "20231123"}], "brand_name": "Brimonidine tartrate and Timolol maleate", "product_id": "71921-188_0b25c3d0-6cf7-cce0-e063-6294a90a8ea9", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Antagonists [MoA]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71921-188", "generic_name": "Brimonidine tartrate and Timolol maleate", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brimonidine tartrate and Timolol maleate", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA201949", "marketing_category": "ANDA", "marketing_start_date": "20231123", "listing_expiration_date": "20261231"}