FDA.reportPublic FDA data

OXBRYTA

Product NDC
72786-101
11-digit product format
727860101
Labeler code
72786
Product ID
72786-101_e27a3e07-438e-49d3-aae3-095e9379c7b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voxelotor
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.
Application
NDA213137
Marketing category
NDA
Marketing start
2019-11-25
Substance
VOXELOTOR
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Hemoglobin S Polymerization Inhibitor [EPC], Hemoglobin S Polymerization Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VOXELOTOR500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ZO554A4Q8
Rxcui2265683, 2265689, 2588070, 2588074, 2619427, 2619428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f462aae3-6ca5-4ac1-bbf8-920d1164ae0aProduct name220220720
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72786-101-012020-07-29C16284748780-1ab0e2407-28db-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA. OXBRYTA ® (voxelotor) tablets, for oral use OXBRYTA ® (voxelotor) tablets for oral suspension Initial U.S. Approval: 2019
72786-101-012020-07-22C16284748780-1ab0e2407-28db-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA. OXBRYTA ® (voxelotor) tablets, for oral use OXBRYTA ® (voxelotor) tablets for oral suspension Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72786-101-01OXBRYTA90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72786-101OXBRYTA (VOXELOTOR) TABLET, FILM COATED OXBRYTA (VOXELOTOR) TABLET, FOR SUSPENSION [GLOBAL BLOOD THERAPEUTICS, INC, A SUBSIDIARY OF PFIZER INC.]13Current NDC, Legacy NDC, 1 package rows20231227_3c557fac-29ec-483f-b691-8a935d4decc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619428OXBRYTA 300 MG Oral TabletPSN3c557fac-29ec-483f-b691-8a935d4decc313
2588074Oxbryta 300 MG Tablet for Oral SuspensionPSN3c557fac-29ec-483f-b691-8a935d4decc313
2265689OXBRYTA 500 MG Oral TabletPSN3c557fac-29ec-483f-b691-8a935d4decc313
2619427voxelotor 300 MG Oral TabletPSN3c557fac-29ec-483f-b691-8a935d4decc313
2588070voxelotor 300 MG Tablet for Oral SuspensionPSN3c557fac-29ec-483f-b691-8a935d4decc313
2265683voxelotor 500 MG Oral TabletPSN3c557fac-29ec-483f-b691-8a935d4decc313
2619428voxelotor 300 MG Oral Tablet [Oxbryta]SBD3c557fac-29ec-483f-b691-8a935d4decc313
2588074voxelotor 300 MG Tablet for Oral Suspension [Oxbryta]SBD3c557fac-29ec-483f-b691-8a935d4decc313
2265689voxelotor 500 MG Oral Tablet [Oxbryta]SBD3c557fac-29ec-483f-b691-8a935d4decc313
2619427voxelotor 300 MG Oral TabletSCD3c557fac-29ec-483f-b691-8a935d4decc313
2588070voxelotor 300 MG Tablet for Oral SuspensionSCD3c557fac-29ec-483f-b691-8a935d4decc313
2265683voxelotor 500 MG Oral TabletSCD3c557fac-29ec-483f-b691-8a935d4decc313
2619428Oxbryta 300 MG Oral TabletSY3c557fac-29ec-483f-b691-8a935d4decc313
2588074Oxbryta 300 MG Tablet for Oral SuspensionSY3c557fac-29ec-483f-b691-8a935d4decc313
2265689Oxbryta 500 MG Oral TabletSY3c557fac-29ec-483f-b691-8a935d4decc313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72786-101-017278601010190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72786-101-01) 2019-11-250000-00-00NoNoCurrent