FDA.reportPublic FDA data

Qulipta

Product NDC
0074-7094
11-digit product format
000747094
Labeler code
0074
Product ID
0074-7094_392c0320-ca25-423a-9bc1-d06f6badab07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atogepant
Dosage form
TABLET
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA215206
Marketing category
NDA
Marketing start
2021-09-30
Substance
ATOGEPANT
Active strength
60 mg/1
Pharmacologic classes
Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Qulipta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOGEPANT60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7CRV8RR151
Rxcui2571836, 2571842, 2571844, 2571846, 2571848, 2571850

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
938c5e24-df14-418b-acfa-11d4ed993b54Product name120220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-7094-04Qulipta4 in 1 BOTTLETABLET419
0074-7094-30Qulipta30 in 1 BOTTLETABLET3019
0074-7094-70Qulipta4 in 1 BOTTLETABLET419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7094-30EA - Each0074-7094cbf736de-d014-49c6-abd7-3f017fb04f9612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7094QULIPTA (ATOGEPANT) TABLET [ABBVIE INC.]15Current NDC, Legacy NDC, 3 package rows20250330_8c8ab8f4-32bd-497a-befa-70c8a51d8d52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2571836atogepant 10 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571844atogepant 30 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571848atogepant 60 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571842QULIPTA 10 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571846QULIPTA 30 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571850QULIPTA 60 MG Oral TabletPSN8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571842atogepant 10 MG Oral Tablet [Qulipta]SBD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571846atogepant 30 MG Oral Tablet [Qulipta]SBD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571850atogepant 60 MG Oral Tablet [Qulipta]SBD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571836atogepant 10 MG Oral TabletSCD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571844atogepant 30 MG Oral TabletSCD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571848atogepant 60 MG Oral TabletSCD8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571842Qulipta 10 MG Oral TabletSY8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571846Qulipta 30 MG Oral TabletSY8c8ab8f4-32bd-497a-befa-70c8a51d8d5219
2571850Qulipta 60 MG Oral TabletSY8c8ab8f4-32bd-497a-befa-70c8a51d8d5219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-7094-04000747094044 TABLET in 1 BOTTLE (0074-7094-04) 4 tablet2021-10-060000-00-00YesNoCurrent
0074-7094-300007470943030 TABLET in 1 BOTTLE (0074-7094-30) 30 tablet2021-09-300000-00-00NoNoCurrent
0074-7094-70000747094704 TABLET in 1 BOTTLE (0074-7094-70) 4 tablet2025-12-17YesNoCurrent