ACYCLOVIR

Product NDC
68084-107
11-digit product format
680840107
Labeler code
68084
Product ID
68084-107_ea3f2ca8-e079-f820-e053-2995a90a5631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075677
Marketing category
ANDA
Marketing start
2014-01-21
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
200 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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-107-01EA - Each68084-107beb3dc98-c6af-44a5-ab96-737277a018f512014-02-04
68084-107-11EA - Each68084-1074e64df8a-83a4-4b28-b766-a7172818632612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-107ACYCLOVIR CAPSULE [AMERICAN HEALTH PACKAGING]7Legacy NDC20241208_9d16ea0c-5b51-43b8-bf1a-bee84a6a764b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-107-0168084010701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-107-01) > 1 CAPSULE in 1 BLISTER PACK (68084-107-11) 100 blister pack2014-01-210000-00-00NoNoCurrent