Acyclovir

Product NDC
82804-005
11-digit product format
828040005
Labeler code
82804
Product ID
82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
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
82804-005-06828040005066 TABLET in 1 BOTTLE (82804-005-06) 6 tablet2024-01-09NoNoHistorical
82804-005-158280400051515 TABLET in 1 BOTTLE (82804-005-15) 15 tablet2024-01-09NoNoHistorical
82804-005-208280400052020 TABLET in 1 BOTTLE (82804-005-20) 20 tablet2024-01-09NoNoHistorical
82804-005-218280400052121 TABLET in 1 BOTTLE (82804-005-21) 21 tablet2024-01-09NoNoHistorical
82804-005-308280400053030 TABLET in 1 BOTTLE (82804-005-30) 30 tablet2023-08-31NoNoHistorical
82804-005-358280400053535 TABLET in 1 BOTTLE (82804-005-35) 35 tablet2024-01-09NoNoHistorical
82804-005-608280400056060 TABLET in 1 BOTTLE (82804-005-60) 60 tablet2023-08-31NoNoHistorical
82804-005-908280400059090 TABLET in 1 BOTTLE (82804-005-90) 90 tablet2023-08-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ACYCLOVIR TABLETS, USP 400 mgProficient Rx LP2024-01-01HUMAN PRESCRIPTION DRUG LABEL2