Acyclovir

Product NDC
68084-108
11-digit product format
680840108
Labeler code
68084
Product ID
68084-108_ea3f34c4-3cf7-5f29-e053-2995a90ac0bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077309
Marketing category
ANDA
Marketing start
2014-01-21
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
400 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
68084-108-01EA - Each68084-10893db5990-d07b-48e1-a899-85406135976412014-02-04
68084-108-11EA - Each68084-10841d0e7aa-b9dd-462a-a87a-45c41945af4a12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-108ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING]8Legacy NDC20241208_70038a69-badc-4073-a13e-ebc9bb8146bc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-108-0168084010801100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-108-01) > 1 TABLET in 1 BLISTER PACK (68084-108-11) 100 blister pack2014-01-210000-00-00NoNoCurrent