FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-2619
11-digit product format
713352619
Labeler code
71335
Product ID
71335-2619_44846c21-7048-4c16-a86e-6bee3469a237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-08-15
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
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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2619-17133526190135 TABLET in 1 BOTTLE (71335-2619-1) 35 tablet2025-05-29NoNoHistorical
71335-2619-27133526190290 TABLET in 1 BOTTLE (71335-2619-2) 90 tablet2025-05-29NoNoHistorical
71335-2619-37133526190321 TABLET in 1 BOTTLE (71335-2619-3) 21 tablet2025-05-29NoNoHistorical