mirvaso

Generic: brimonidine tartrate

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mirvaso
Generic Name brimonidine tartrate
Labeler galderma laboratories, l.p.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

brimonidine tartrate 5 mg/g

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-5980
Product ID 0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204708
Listing Expiration 2026-12-31
Marketing Start 2013-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02995980
Hyphenated Format 0299-5980

Supplemental Identifiers

RxCUI
1437707 1437709
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 mirvaso (source: ndc)
Generic Name brimonidine tartrate (source: ndc)
Application Number NDA204708 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE
  • 2 g in 1 TUBE (0299-5980-02)
  • 30 g in 1 TUBE (0299-5980-30)
  • 1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP
  • 45 g in 1 TUBE (0299-5980-45)
source: ndc

Packages (5)

0299-5980-00 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE 0299-5980-02 2 g in 1 TUBE (0299-5980-02) 0299-5980-30 30 g in 1 TUBE (0299-5980-30) 0299-5980-35 1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP 0299-5980-45 45 g in 1 TUBE (0299-5980-45)

Ingredients (1)

brimonidine tartrate (5 mg/g)

Linked Drug Pages (1)

Mirvaso ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "253bf4a2-3c4d-f4af-e063-6394a90a0b0a", "openfda": {"unii": ["4S9CL2DY2H"], "rxcui": ["1437707", "1437709"], "spl_set_id": ["f6a4353f-ae69-4214-901f-e5d42a6fbde7"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 TUBE in 1 BLISTER PACK (0299-5980-00)  / 2 g in 1 TUBE", "package_ndc": "0299-5980-00", "marketing_start_date": "20130823"}, {"sample": true, "description": "2 g in 1 TUBE (0299-5980-02)", "package_ndc": "0299-5980-02", "marketing_start_date": "20130823"}, {"sample": false, "description": "30 g in 1 TUBE (0299-5980-30)", "package_ndc": "0299-5980-30", "marketing_start_date": "20130823"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0299-5980-35)  / 30 g in 1 BOTTLE, PUMP", "package_ndc": "0299-5980-35", "marketing_start_date": "20130823"}, {"sample": false, "description": "45 g in 1 TUBE (0299-5980-45)", "package_ndc": "0299-5980-45", "marketing_start_date": "20130823"}], "brand_name": "Mirvaso", "product_id": "0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0a", "dosage_form": "GEL", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0299-5980", "generic_name": "brimonidine tartrate", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirvaso", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "5 mg/g"}], "application_number": "NDA204708", "marketing_category": "NDA", "marketing_start_date": "20130823", "listing_expiration_date": "20261231"}