Vocabria
These highlights do not include all the information needed to use VOCABRIA safely and effectively. See full prescribing information for VOCABRIA.VOCABRIA (cabotegravir) tablets, for oral useInitial U.S. Approval: 2021
Approved
Approval ID
66d450fb-cca4-476c-b0c7-c0730e3e4cf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cabotegravir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-248
Application NumberNDA212887
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabotegravir sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2023
FDA Product Classification
INGREDIENTS (8)
CABOTEGRAVIR SODIUMActive
Quantity: 30 mg in 1 1
Code: 3L12PT535M
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT