qulipta

Generic: atogepant

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

Drug Facts

Product Profile

Brand Name qulipta
Generic Name atogepant
Labeler abbvie inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atogepant 10 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-7095
Product ID 0074-7095_392c0320-ca25-423a-9bc1-d06f6badab07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215206
Listing Expiration 2027-12-31
Marketing Start 2021-09-30

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 00747095
Hyphenated Format 0074-7095

Supplemental Identifiers

RxCUI
2571836 2571842 2571844 2571846 2571848 2571850
UPC
0300747096305 0300747094301
UNII
7CRV8RR151
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 qulipta (source: ndc)
Generic Name atogepant (source: ndc)
Application Number NDA215206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0074-7095-30)
source: ndc

Packages (1)

Ingredients (1)

atogepant (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "392c0320-ca25-423a-9bc1-d06f6badab07", "openfda": {"nui": ["N0000193917", "N0000193918"], "upc": ["0300747096305", "0300747094301"], "unii": ["7CRV8RR151"], "rxcui": ["2571836", "2571842", "2571844", "2571846", "2571848", "2571850"], "spl_set_id": ["8c8ab8f4-32bd-497a-befa-70c8a51d8d52"], "pharm_class_epc": ["Calcitonin Gene-related Peptide Receptor Antagonist [EPC]"], "pharm_class_moa": ["Calcitonin Gene-related Peptide Receptor Antagonists [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0074-7095-30)", "package_ndc": "0074-7095-30", "marketing_start_date": "20210930"}], "brand_name": "Qulipta", "product_id": "0074-7095_392c0320-ca25-423a-9bc1-d06f6badab07", "dosage_form": "TABLET", "pharm_class": ["Calcitonin Gene-related Peptide Receptor Antagonist [EPC]", "Calcitonin Gene-related Peptide Receptor Antagonists [MoA]"], "product_ndc": "0074-7095", "generic_name": "Atogepant", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qulipta", "active_ingredients": [{"name": "ATOGEPANT", "strength": "10 mg/1"}], "application_number": "NDA215206", "marketing_category": "NDA", "marketing_start_date": "20210930", "listing_expiration_date": "20271231"}