ACYCLOVIR
VALACYCLOVIR HYDROCHLORIDE
Approved
Approval ID
97a10bb6-52c0-495d-e053-2995a90a60a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2023
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VALACYCLOVIR HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-037
Application NumberANDA201506
Product Classification
M
Marketing Category
C73584
G
Generic Name
VALACYCLOVIR HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: G447S0T1VC
Classification: ACTIR
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ACYCLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-232
Application NumberANDA075382
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACYCLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACYCLOVIRActive
Quantity: 800 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VALACYCLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-051
Application NumberANDA203047
Product Classification
M
Marketing Category
C73584
G
Generic Name
VALACYCLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VALACYCLOVIR HYDROCHLORIDEActive
Quantity: 1 g in 1 1
Code: G447S0T1VC
Classification: ACTIR