FDA.reportPublic FDA data

acyclovir

Product NDC
70518-1363
11-digit product format
705181363
Labeler code
70518
Product ID
70518-1363_4bd3791a-9cbb-3c48-e063-6394a90a6d7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204314
Marketing category
ANDA
Marketing start
2018-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1363-0acyclovir15 in 1 BOTTLE, PLASTICTABLET158
70518-1363-1acyclovir30 in 1 BOTTLE, PLASTICTABLET308
70518-1363-2acyclovir30 in 1 BLISTER PACKTABLET308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8
197311acyclovir 400 MG Oral TabletSCD8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8
197311acycycloguanosine 400 MG Oral TabletSY8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1363-07051813630015 TABLET in 1 BOTTLE, PLASTIC (70518-1363-0) 15 tablet2018-08-09NoNoHistorical
70518-1363-17051813630130 TABLET in 1 BOTTLE, PLASTIC (70518-1363-1) 30 tablet2018-12-27NoNoHistorical
70518-1363-27051813630230 TABLET in 1 BLISTER PACK (70518-1363-2) 30 tablet2026-02-17NoNoHistorical