brimonidine

Generic: brimonidine

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brimonidine
Generic Name brimonidine
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

brimonidine tartrate 5 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-078
Product ID 45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209158
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802078
Hyphenated Format 45802-078

Supplemental Identifiers

RxCUI
1437707
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 (source: ndc)
Generic Name brimonidine (source: ndc)
Application Number ANDA209158 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP
source: ndc

Packages (1)

45802-078-30 1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP

Ingredients (1)

brimonidine tartrate (5 mg/g)

Linked Drug Pages (1)

BRIMONIDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["1437707"], "spl_set_id": ["c899b329-cc5e-4443-8e94-451314de47c9"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (45802-078-30)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "45802-078-30", "marketing_start_date": "20230101"}], "brand_name": "BRIMONIDINE", "product_id": "45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75", "dosage_form": "GEL", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "45802-078", "generic_name": "brimonidine", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BRIMONIDINE", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "5 mg/g"}], "application_number": "ANDA209158", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}