NDC 68712-049

Sitavig

Acyclovir

Sitavig is a Buccal Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cipher Pharmaceuticals Us Llc. The primary component is Acyclovir.

Product ID68712-049_4d76b99b-3aba-36b3-e054-00144ff88e88
NDC68712-049
Product TypeHuman Prescription Drug
Proprietary NameSitavig
Generic NameAcyclovir
Dosage FormTablet, Delayed Release
Route of AdministrationBUCCAL
Marketing Start Date2014-03-20
Marketing CategoryNDA / NDA
Application NumberNDA203791
Labeler NameCipher Pharmaceuticals US LLC
Substance NameACYCLOVIR
Active Ingredient Strength50 mg/1
Pharm ClassesDNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68712-049-02

1 BLISTER PACK in 1 CARTON (68712-049-02) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2014-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68712-049-01 [68712004901]

Sitavig TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA203791
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-20
Marketing End Date2014-08-22

NDC 68712-049-02 [68712004902]

Sitavig TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA203791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACYCLOVIR50 mg/1

OpenFDA Data

SPL SET ID:00f7425a-6236-47ff-a087-f28f8cdb1aec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1423662
  • 1493276
  • Pharmacological Class

    • DNA Polymerase Inhibitors [MoA]
    • Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Nucleoside Analog [EXT]

    NDC Crossover Matching brand name "Sitavig" or generic name "Acyclovir"

    NDCBrand NameGeneric Name
    68712-049SitavigSitavig
    71403-049SitavigSitavig
    0093-3630Acycloviracyclovir
    0093-8940AcyclovirAcyclovir
    0093-8943AcyclovirAcyclovir
    0093-8947AcyclovirAcyclovir
    0143-9657AcyclovirAcyclovir
    0143-9658AcyclovirAcyclovir
    0168-0825acycloviracyclovir
    0378-8700Acycloviracyclovir
    0378-8712AcyclovirAcyclovir
    0440-6030AcyclovirAcyclovir
    0440-7033acycloviracyclovir
    0472-0082AcyclovirAcyclovir
    0591-1159Acycloviracyclovir
    0713-0630AcyclovirAcyclovir
    0904-5789ACYCLOVIRACYCLOVIR
    0904-5790acycloviracyclovir
    10544-039Acycloviracyclovir
    10544-089Acycloviracyclovir
    10544-101AcyclovirAcyclovir
    0187-0993Zoviraxacyclovir
    0187-0994Zoviraxacyclovir
    0378-9735ZoviraxAcyclovir

    Trademark Results [Sitavig]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SITAVIG
    SITAVIG
    85247490 4044319 Live/Registered
    VECTANS PHARMA
    2011-02-21

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