Apretude

Product NDC
49702-280
11-digit product format
497020280
Labeler code
49702
Product ID
49702-280_cedc4b34-5c83-4d5f-a47f-7d5e93f71459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cabotegravir
Dosage form
KIT
Labeler
ViiV Healthcare Company
Application
NDA215499
Marketing category
NDA
Marketing start
2024-03-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2588077, 2588080

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ba89f589-ed67-48fe-9931-d0915055348aProduct name120220728
f306ec07-0d7d-45ce-ade0-e6c8659560b1Product name120210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dc78e92e-f760-407c-94a4-da4867af6b2bProduct name120210204
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-238-61Apretude3 mL in 1 VIALINJECTION, SUSPENSION, EXTENDED3 mL200 mg in 1mL8
49702-280-63Apretude1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-280APRETUDE (CABOTEGRAVIR) KIT [VIIV HEALTHCARE COMPANY]8Current NDC, 2 package rows20250419_4338428e-43d4-4e02-ac9d-bd98e738a7da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588080Apretude 600 MG in 3 ML Extended Release InjectionPSN4338428e-43d4-4e02-ac9d-bd98e738a7da8
2588077cabotegravir 600 MG in 3 ML Extended Release InjectionPSN4338428e-43d4-4e02-ac9d-bd98e738a7da8
25880803 ML cabotegravir 200 MG/ML Injection [Apretude]SBD4338428e-43d4-4e02-ac9d-bd98e738a7da8
25880773 ML cabotegravir 200 MG/ML InjectionSCD4338428e-43d4-4e02-ac9d-bd98e738a7da8
2588080Apretude 200 MG/ML per 3 ML InjectionSY4338428e-43d4-4e02-ac9d-bd98e738a7da8
2588080Apretude 600 MG per 3 ML InjectionSY4338428e-43d4-4e02-ac9d-bd98e738a7da8
2588077cabotegravir 600 MG per 3 ML InjectionSY4338428e-43d4-4e02-ac9d-bd98e738a7da8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49702-238-61497020238613 mL in 1 VIAL3 mlHistorical
49702-280-63497020280631 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61) 1 kit2024-03-31YesNoCurrent