Sitavig
These highlights do not include all the information needed to use SITAVIG safely and effectively. See full prescribing information for SITAVIG. SITAVIG (acyclovir) buccal tablets Initial U.S. Approval: 1982
Approved
Approval ID
cd6e902d-5753-49ec-bec8-b27176ed978e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2020
Manufacturers
FDA
EPI Health, Inc
DUNS: 080638894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71403-049
Application NumberNDA203791
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationBUCCAL
Effective DateDecember 1, 2019
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ACYCLOVIRActive
Quantity: 50 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT