Acyclovir

Product NDC
70518-4450
11-digit product format
705184450
Labeler code
70518
Product ID
70518-4450_3ccb410d-eef3-d973-e063-6394a90a419d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209366
Marketing category
ANDA
Marketing start
2025-08-19
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
X4HES1O11FACYCLOVIR59277-89-3ACYCLOVIR

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4450-07051844500030 TABLET in 1 BLISTER PACK (70518-4450-0) 30 tablet2025-08-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acyclovir Tablets, USPREMEDYREPACK INC.2025-08-20HUMAN PRESCRIPTION DRUG LABEL1