FDA.reportPublic FDA data

Rukobia

Product NDC
49702-250
11-digit product format
497020250
Labeler code
49702
Product ID
49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fostemsavir tromethamine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA212950
Marketing category
NDA
Marketing start
2020-07-02
Substance
FOSTEMSAVIR TROMETHAMINE
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSTEMSAVIR TROMETHAMINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2X513P36U0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b2c5f20-df5e-444f-86fd-d6e77e7ca52cProduct name120210119

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-250-18Rukobia60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
49702-250-18Rukobia1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-250-18EA - Each49702-25066fe04c5-dbd1-4070-b2d0-d38b96ee7a8512020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-250RUKOBIA (FOSTEMSAVIR TROMETHAMINE) TABLET, FILM COATED, EXTENDED RELEASE [VIIV HEALTHCARE COMPANY]7Current NDC, Legacy NDC, 2 package rows20240616_a21006b7-6d6f-4f06-81b4-17978756452b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380549fostemsavir 600 MG 12HR Extended Release Oral TabletPSNa21006b7-6d6f-4f06-81b4-17978756452b8
2380551Rukobia 600 MG 12HR Extended Release Oral TabletPSNa21006b7-6d6f-4f06-81b4-17978756452b8
238055112 HR fostemsavir 600 MG Extended Release Oral Tablet [Rukobia]SBDa21006b7-6d6f-4f06-81b4-17978756452b8
238054912 HR fostemsavir 600 MG Extended Release Oral TabletSCDa21006b7-6d6f-4f06-81b4-17978756452b8
238054912 HR fostemsavir 600 MG (equivalent to 725 MG fostemsavir tromethamine) Extended Release Oral TabletSYa21006b7-6d6f-4f06-81b4-17978756452b8
238055112 HR fostemsavir 600 MG (equivalent to 725 MG fostemsavir tromethamine) Extended Release Oral Tablet [Rukobia]SYa21006b7-6d6f-4f06-81b4-17978756452b8
2380549fostemsavir 600 MG 12 HR Extended Release Oral TabletSYa21006b7-6d6f-4f06-81b4-17978756452b8
2380551Rukobia 600 MG 12 HR Extended Release Oral TabletSYa21006b7-6d6f-4f06-81b4-17978756452b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49702-250-18497020250181 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-07-020000-00-00NoNoCurrent