FDA.reportPublic FDA data

UBRELVY

Product NDC
0023-6501
11-digit product format
000236501
Labeler code
0023
Product ID
0023-6501_07fd3ef4-ef45-4b86-a6ab-75457fbe68ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ubrogepant
Dosage form
TABLET
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA211765
Marketing category
NDA
Marketing start
2019-12-23
Substance
UBROGEPANT
Active strength
100 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UBRELVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UBROGEPANT100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAD0O8X2QJR
Rxcui2268221, 2268227, 2268229, 2268231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
974ec6d6-bdb6-4dfa-b124-6fbf6e8df619Product name120200605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-6501-01UBRELVY1 in 1 BOXTABLET127
0023-6501-01UBRELVY1 in 1 PACKETTABLET127
0023-6501-02UBRELVY1 in 1 PACKETTABLET127
0023-6501-10UBRELVY10 in 1 BOXTABLET1027
0023-6501-16UBRELVY16 in 1 BOXTABLET1627
0023-6501-30UBRELVY30 in 1 BOXTABLET3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6501-01EA - Each0023-6501d2085d82-4a53-4680-b0ee-017cf674c93212024-10-04
0023-6501-02EA - Each0023-65011f5a198e-c38f-4579-b874-cf3e179a8d7d12020-02-13
0023-6501-10EA - Each0023-65011097cd70-1b67-4562-9c4f-3fd3989375fa12020-02-13
0023-6501-16EA - Each0023-65012d54611f-1ac0-4eb3-93fa-a4f070683bc912022-02-07
0023-6501-30EA - Each0023-6501ddf2e9e5-484b-4af3-92e2-4bb55c3bea7f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-6501UBRELVY (UBROGEPANT) TABLET [ALLERGAN, INC.]26Current NDC, Legacy NDC, 6 package rows20250328_fd9f9458-fd96-4688-be3f-f77b3d1af6ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2268227ubrelvy 100 MG Oral TabletPSNfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268231ubrelvy 50 MG Oral TabletPSNfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268221ubrogepant 100 MG Oral TabletPSNfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268229ubrogepant 50 MG Oral TabletPSNfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268227ubrogepant 100 MG Oral Tablet [Ubrelvy]SBDfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268231ubrogepant 50 MG Oral Tablet [Ubrelvy]SBDfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268221ubrogepant 100 MG Oral TabletSCDfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268229ubrogepant 50 MG Oral TabletSCDfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268227Ubrelvy 100 MG Oral TabletSYfd9f9458-fd96-4688-be3f-f77b3d1af6ab27
2268231Ubrelvy 50 MG Oral TabletSYfd9f9458-fd96-4688-be3f-f77b3d1af6ab27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-6501-01000236501011 PACKET in 1 BOX (0023-6501-01) / 1 TABLET in 1 PACKET1 packet2019-12-23YesNoCurrent
0023-6501-02000236501021 in 1 PACKETHistorical
0023-6501-100002365011010 PACKET in 1 BOX (0023-6501-10) / 1 TABLET in 1 PACKET (0023-6501-02) 10 packet2019-12-230000-00-00NoNoCurrent
0023-6501-160002365011616 PACKET in 1 BOX (0023-6501-16) / 1 TABLET in 1 PACKET (0023-6501-02) 16 packet2019-12-230000-00-00NoNoCurrent
0023-6501-300002365013030 PACKET in 1 BOX (0023-6501-30) / 1 TABLET in 1 PACKET (0023-6501-02) 30 packet2019-12-230000-00-00NoNoCurrent