Acyclovir

Product NDC
68084-109
11-digit product format
680840109
Labeler code
68084
Product ID
68084-109_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
800 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
68084-109-01EA - Each68084-1094b6c6325-9c4e-469b-b981-59afdc8d8e1f12014-02-04
68084-109-11EA - Each68084-1093d7bfb1b-4617-460b-a02e-3d264ad2b53412014-02-04

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
68084-109ACYCLOVIR 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
68084-109-0168084010901100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-109-01) > 1 TABLET in 1 BLISTER PACK (68084-109-11) 100 blister pack2014-01-210000-00-00NoNoCurrent