acyclovir

Product NDC
0904-5790
11-digit product format
009045790
Labeler code
0904
Product ID
0904-5790_af7044ff-8bde-4859-ba31-9297002857a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077309
Marketing category
ANDA
Marketing start
2007-02-09
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
0904-5790-61EA - Each0904-5790a7b156f2-74af-4b45-a13d-71d26609149b12013-10-17

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5790ACYCLOVIR TABLET [MAJOR PHARMACEUTICALS]9Legacy NDC20250418_1bc88200-be9b-4fab-bec2-8f303bd1c366.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5790-6100904579061100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5790-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2007-02-090000-00-00NoNoCurrent