FDA.reportPublic FDA data

Ojjaara

Product NDC
81864-101
11-digit product format
818640101
Labeler code
81864
Product ID
81864-101_0439799e-24bf-4208-bc66-a04aa9ce9533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Momelotinib
Dosage form
TABLET
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA216873
Marketing category
NDA
Marketing start
2023-09-15
Substance
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
Active strength
200 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLDX8893L5D
Rxcui2665210, 2665216, 2665218, 2665220, 2665222, 2665224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
231b345c-e8f7-4afa-9c0d-901845058cbdProduct name120230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81864-101-30Ojjaara30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81864-101-30EA - Each81864-101e35ac5b0-1857-4aed-8a54-04db3e65876612023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81864-101OJJAARA (MOMELOTINIB) TABLET [GLAXOSMITHKLINE LLC]6Current NDC, 1 package rows20250430_4a672fd1-eb7b-4aa9-9b23-845e4b5dc400.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2665210momelotinib 100 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665218momelotinib 150 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665222momelotinib 200 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665216Ojjaara 100 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665220Ojjaara 150 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665224Ojjaara 200 MG Oral TabletPSN4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665216momelotinib 100 MG Oral Tablet [Ojjaara]SBD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665220momelotinib 150 MG Oral Tablet [Ojjaara]SBD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665224momelotinib 200 MG Oral Tablet [Ojjaara]SBD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665210momelotinib 100 MG Oral TabletSCD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665218momelotinib 150 MG Oral TabletSCD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665222momelotinib 200 MG Oral TabletSCD4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665210momelotinib 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665218momelotinib 150 MG (equivalent to 182.91 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665222momelotinib 200 MG (equivalent to 243.88 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665216Ojjaara 100 MG (equivalent to 121.94 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665220Ojjaara 150 MG (equivalent to 182.91 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008
2665224Ojjaara 200 MG (equivalent to 243.88 MG momelotinib dihydrochloride monohydrate) Oral TabletSY4a672fd1-eb7b-4aa9-9b23-845e4b5dc4008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81864-101-308186401013030 TABLET in 1 BOTTLE (81864-101-30) 30 tablet2023-09-15NoNoCurrent