ADEFOVIR DIPIVOXIL
These highlights do not include all the information needed to use ADEFOVIR DIPIVOXIL TABLETS safely and effectively. See full prescribing information for ADEFOVIR DIPIVOXIL TABLETS.
Approved
Approval ID
e047f3b2-feae-4c5e-9d07-1fefb4c0ec25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ADEFOVIR DIPIVOXIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-003
Application NumberANDA202051
Product Classification
M
Marketing Category
C73584
G
Generic Name
ADEFOVIR DIPIVOXIL
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ADEFOVIR DIPIVOXILActive
Quantity: 10 mg in 1 1
Code: U6Q8Z01514
Classification: ACTIB
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT