ubrelvy

Generic: ubrogepant

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ubrelvy
Generic Name ubrogepant
Labeler allergan, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ubrogepant 50 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-6498
Product ID 0023-6498_07fd3ef4-ef45-4b86-a6ab-75457fbe68ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211765
Listing Expiration 2026-12-31
Marketing Start 2019-12-23

Pharmacologic Class

Established (EPC)
calcitonin gene-related peptide receptor antagonist [epc]
Mechanism of Action
calcitonin gene-related peptide receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00236498
Hyphenated Format 0023-6498

Supplemental Identifiers

RxCUI
2268221 2268227 2268229 2268231
UNII
AD0O8X2QJR
NUI
N0000193917 N0000193918

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 ubrelvy (source: ndc)
Generic Name ubrogepant (source: ndc)
Application Number NDA211765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET
  • 4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET
  • 10 PACKET in 1 BOX (0023-6498-10) / 1 TABLET in 1 PACKET (0023-6498-02)
  • 16 PACKET in 1 BOX (0023-6498-16) / 1 TABLET in 1 PACKET (0023-6498-02)
  • 30 PACKET in 1 BOX (0023-6498-30) / 1 TABLET in 1 PACKET (0023-6498-02)
source: ndc

Packages (5)

0023-6498-01 1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET 0023-6498-04 4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET 0023-6498-10 10 PACKET in 1 BOX (0023-6498-10) / 1 TABLET in 1 PACKET (0023-6498-02) 0023-6498-16 16 PACKET in 1 BOX (0023-6498-16) / 1 TABLET in 1 PACKET (0023-6498-02) 0023-6498-30 30 PACKET in 1 BOX (0023-6498-30) / 1 TABLET in 1 PACKET (0023-6498-02)

Ingredients (1)

ubrogepant (50 mg/1)

Linked Drug Pages (1)

UBRELVY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "07fd3ef4-ef45-4b86-a6ab-75457fbe68ca", "openfda": {"nui": ["N0000193917", "N0000193918"], "unii": ["AD0O8X2QJR"], "rxcui": ["2268221", "2268227", "2268229", "2268231"], "spl_set_id": ["fd9f9458-fd96-4688-be3f-f77b3d1af6ab"], "pharm_class_epc": ["Calcitonin Gene-related Peptide Receptor Antagonist [EPC]"], "pharm_class_moa": ["Calcitonin Gene-related Peptide Receptor Antagonists [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 PACKET in 1 BOX (0023-6498-01)  / 1 TABLET in 1 PACKET", "package_ndc": "0023-6498-01", "marketing_start_date": "20191223"}, {"sample": true, "description": "4 PACKET in 1 BOX (0023-6498-04)  / 1 TABLET in 1 PACKET", "package_ndc": "0023-6498-04", "marketing_start_date": "20191223"}, {"sample": false, "description": "10 PACKET in 1 BOX (0023-6498-10)  / 1 TABLET in 1 PACKET (0023-6498-02)", "package_ndc": "0023-6498-10", "marketing_start_date": "20191223"}, {"sample": false, "description": "16 PACKET in 1 BOX (0023-6498-16)  / 1 TABLET in 1 PACKET (0023-6498-02)", "package_ndc": "0023-6498-16", "marketing_start_date": "20191223"}, {"sample": false, "description": "30 PACKET in 1 BOX (0023-6498-30)  / 1 TABLET in 1 PACKET (0023-6498-02)", "package_ndc": "0023-6498-30", "marketing_start_date": "20191223"}], "brand_name": "UBRELVY", "product_id": "0023-6498_07fd3ef4-ef45-4b86-a6ab-75457fbe68ca", "dosage_form": "TABLET", "pharm_class": ["Calcitonin Gene-related Peptide Receptor Antagonist [EPC]", "Calcitonin Gene-related Peptide Receptor Antagonists [MoA]"], "product_ndc": "0023-6498", "generic_name": "ubrogepant", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UBRELVY", "active_ingredients": [{"name": "UBROGEPANT", "strength": "50 mg/1"}], "application_number": "NDA211765", "marketing_category": "NDA", "marketing_start_date": "20191223", "listing_expiration_date": "20261231"}