FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-9721
11-digit product format
713359721
Labeler code
71335
Product ID
71335-9721_637f4303-bd11-4934-b45d-d353b402cffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9721-071335972100500 TABLET in 1 BOTTLE, PLASTIC (71335-9721-0) 500 tablet2024-09-06NoNoHistorical
71335-9721-17133597210125 TABLET in 1 BOTTLE, PLASTIC (71335-9721-1) 25 tablet2024-09-06NoNoHistorical
71335-9721-27133597210235 TABLET in 1 BOTTLE, PLASTIC (71335-9721-2) 35 tablet2024-09-06NoNoHistorical
71335-9721-37133597210330 TABLET in 1 BOTTLE, PLASTIC (71335-9721-3) 30 tablet2024-09-06NoNoHistorical
71335-9721-47133597210460 TABLET in 1 BOTTLE, PLASTIC (71335-9721-4) 60 tablet2024-09-06NoNoHistorical
71335-9721-57133597210550 TABLET in 1 BOTTLE, PLASTIC (71335-9721-5) 50 tablet2024-09-06NoNoHistorical
71335-9721-67133597210610 TABLET in 1 BOTTLE, PLASTIC (71335-9721-6) 10 tablet2024-09-06NoNoHistorical
71335-9721-77133597210740 TABLET in 1 BOTTLE, PLASTIC (71335-9721-7) 40 tablet2024-09-06NoNoHistorical
71335-9721-87133597210821 TABLET in 1 BOTTLE, PLASTIC (71335-9721-8) 21 tablet2024-09-06NoNoHistorical
71335-9721-97133597210990 TABLET in 1 BOTTLE, PLASTIC (71335-9721-9) 90 tablet2024-09-06NoNoHistorical