FDA.reportPublic FDA data

acyclovir

Product NDC
70518-0427
11-digit product format
705180427
Labeler code
70518
Product ID
70518-0427_47f67704-3da4-510a-e063-6294a90ae0a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077309
Marketing category
ANDA
Marketing start
2017-04-17
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

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 startMarketing endSampleExclude flagStatus
70518-0427-07051804270015 TABLET in 1 BOTTLE, PLASTIC (70518-0427-0) 15 tablet2017-04-170000-00-00NoNoCurrent
70518-0427-17051804270130 TABLET in 1 BOTTLE, PLASTIC (70518-0427-1) 30 tablet2017-04-212026-12-31NoNoCurrent
70518-0427-27051804270221 TABLET in 1 BOTTLE, PLASTIC (70518-0427-2) 21 tablet2017-04-240000-00-00NoNoCurrent
70518-0427-37051804270330 TABLET in 1 BOTTLE, PLASTIC (70518-0427-3) 30 tablet2021-09-200000-00-00NoNoCurrent