gemtesa

Generic: vibegron

Labeler: sumitomo pharma america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gemtesa
Generic Name vibegron
Labeler sumitomo pharma america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vibegron 75 mg/1

Manufacturer
Sumitomo Pharma America, Inc.

Identifiers & Regulatory

Product NDC 73336-075
Product ID 73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213006
Listing Expiration 2026-12-31
Marketing Start 2020-12-29

Pharmacologic Class

Established (EPC)
beta3-adrenergic agonist [epc]
Mechanism of Action
adrenergic beta3-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73336075
Hyphenated Format 73336-075

Supplemental Identifiers

RxCUI
2472315 2472321
UNII
M5TSE03W5U
NUI
N0000185008 N0000185007

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 gemtesa (source: ndc)
Generic Name vibegron (source: ndc)
Application Number NDA213006 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE
  • 30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)
source: ndc

Packages (3)

73336-075-07 1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE 73336-075-30 30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30) 73336-075-90 90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)

Ingredients (1)

vibegron (75 mg/1)

Linked Drug Pages (1)

GEMTESA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6744a1cf-7abb-4623-85e3-8f67a9eb19d4", "openfda": {"nui": ["N0000185008", "N0000185007"], "unii": ["M5TSE03W5U"], "rxcui": ["2472315", "2472321"], "spl_set_id": ["25f21d25-14f8-4fda-91f6-7aa8b68aa1c8"], "pharm_class_epc": ["beta3-Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic beta3-Agonists [MoA]"], "manufacturer_name": ["Sumitomo Pharma America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (73336-075-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "73336-075-07", "marketing_start_date": "20201229"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)", "package_ndc": "73336-075-30", "marketing_start_date": "20201229"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)", "package_ndc": "73336-075-90", "marketing_start_date": "20201229"}], "brand_name": "GEMTESA", "product_id": "73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta3-Agonists [MoA]", "beta3-Adrenergic Agonist [EPC]"], "product_ndc": "73336-075", "generic_name": "vibegron", "labeler_name": "Sumitomo Pharma America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GEMTESA", "active_ingredients": [{"name": "VIBEGRON", "strength": "75 mg/1"}], "application_number": "NDA213006", "marketing_category": "NDA", "marketing_start_date": "20201229", "listing_expiration_date": "20261231"}