FDA.reportPublic FDA data

SIRTURO

Product NDC
59676-702
11-digit product format
596760702
Labeler code
59676
Product ID
59676-702_415acee9-3121-56fb-e063-6394a90a9d83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bedaquiline Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Janssen Products, LP
Application
NDA204384
Marketing category
NDA
Marketing start
2020-05-27
Substance
BEDAQUILINE FUMARATE
Active strength
20 mg/1
Pharmacologic classes
Diarylquinoline Antimycobacterial [EPC], Diarylquinolines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEDAQUILINE FUMARATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP04QX2C1A5
Rxcui1364509, 1364515, 2373939, 2373941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91496dbd-18e1-6892-8e92-13b75981d3f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-702-60SIRTURO60 in 1 BOTTLETABLET6033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-702-60EA - Each59676-7028032accd-433c-4731-a698-350fa0307ca012020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bedaquiline FumarateACTIVE INGREDIENTP04QX2C1A5SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
BedaquilineACTIVE MOIETY78846I289YSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
hypromellose 2910 (15 mPa.s)INACTIVE INGREDIENT36SFW2JZ0WSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
magnesium stearateINACTIVE INGREDIENT70097M6I30SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
starch, cornINACTIVE INGREDIENTO8232NY3SJSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8
waterINACTIVE INGREDIENT059QF0KO0RSIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-702SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]28Current NDC, Legacy NDC, 1 package rows20240802_1534c9ae-4948-4cf4-9f66-222a99db6d0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364509bedaquiline 100 MG Oral TabletPSN1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373939bedaquiline 20 MG Oral TabletPSN1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364515Sirturo 100 MG Oral TabletPSN1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373941Sirturo 20 MG Oral TabletPSN1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364515bedaquiline 100 MG Oral Tablet [Sirturo]SBD1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373941bedaquiline 20 MG Oral Tablet [Sirturo]SBD1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364509bedaquiline 100 MG Oral TabletSCD1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373939bedaquiline 20 MG Oral TabletSCD1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364509bedaquiline 100 MG (as bedaquiline fumarate 120.9 MG) Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373939bedaquiline 20 MG (as bedaquiline fumarate 24.18 MG) Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364515Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33
1364515Sirturo 100 MG Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373941Sirturo 20 MG (as bedaquiline fumarate 24.18 MG) Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33
2373941Sirturo 20 MG Oral TabletSY1534c9ae-4948-4cf4-9f66-222a99db6d0e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59676-702-605967607026060 TABLET in 1 BOTTLE (59676-702-60) 60 tablet2020-05-270000-00-00NoNoCurrent