Acyclovir

Product NDC
70518-4414
11-digit product format
705184414
Labeler code
70518
Product ID
70518-4414_3b8ace38-a6f1-27bc-e063-6394a90aff8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209366
Marketing category
ANDA
Marketing start
2025-07-31
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
X4HES1O11FACYCLOVIR59277-89-3ACYCLOVIR

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4414-07051844140030 TABLET in 1 BLISTER PACK (70518-4414-0) 30 tablet2025-07-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acyclovir Tablets, USPREMEDYREPACK INC.2025-08-04HUMAN PRESCRIPTION DRUG LABEL1