Home NDC 68712-049 Sitavig
Product NDC 68712-049
11-digit product format 687120049
Labeler code 68712
Product ID 68712-049_4d76b99b-3aba-36b3-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET, DELAYED RELEASE
Route BUCCAL
Labeler Cipher Pharmaceuticals US LLC
Application NDA203791
Marketing category NDA
Marketing start 2014-03-20
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 50 mg/1
Pharmacologic classes 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 exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68712-049-02 Sitavig 2 in 1 BLISTER PACK TABLET, DELAYED RELEASE 2 7 68712-049-02 Sitavig 1 in 1 CARTON TABLET, DELAYED RELEASE 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 ACYCLOVIR ACTIVE MOIETY X4HES1O11F SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 POVIDONE INACTIVE INGREDIENT FZ989GH94E SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68712-049 SITAVIG (ACYCLOVIR) TABLET, DELAYED RELEASE [CIPHER PHARMACEUTICALS US LLC] 7 Legacy NDC, 2 package rows 20170419_00f7425a-6236-47ff-a087-f28f8cdb1aec.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68712-049-02 68712004902 2 in 1 BLISTER PACK Historical