FDA.reportPublic FDA data

Acyclovir

Product NDC
70518-2455
11-digit product format
705182455
Labeler code
70518
Product ID
70518-2455_4a291680-febd-5eac-e063-6394a90ab919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2019-11-25
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
70518-2455-0Acyclovir30 in 1 BLISTER PACKTABLET3015
70518-2455-1Acyclovir15 in 1 BOTTLE, PLASTICTABLET1515
70518-2455-2Acyclovir30 in 1 BOTTLE, PLASTICTABLET3015
70518-2455-3Acyclovir21 in 1 BOTTLE, PLASTICTABLET2115
70518-2455-4Acyclovir50 in 1 BOTTLE, PLASTICTABLET5015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2455ACYCLOVIR TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 5 package rows20250316_6d0e492e-5359-49e8-812d-8c8e2e5d42f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN6d0e492e-5359-49e8-812d-8c8e2e5d42f815
197311acyclovir 400 MG Oral TabletSCD6d0e492e-5359-49e8-812d-8c8e2e5d42f815
197311acycycloguanosine 400 MG Oral TabletSY6d0e492e-5359-49e8-812d-8c8e2e5d42f815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2455-07051824550030 TABLET in 1 BLISTER PACK (70518-2455-0) 30 tablet2019-11-250000-00-00NoNoCurrent
70518-2455-17051824550115 TABLET in 1 BOTTLE, PLASTIC (70518-2455-1) 15 tablet2020-09-080000-00-00NoNoCurrent
70518-2455-27051824550230 TABLET in 1 BOTTLE, PLASTIC (70518-2455-2) 30 tablet2020-10-230000-00-00NoNoCurrent
70518-2455-37051824550321 TABLET in 1 BOTTLE, PLASTIC (70518-2455-3) 21 tablet2021-08-250000-00-00NoNoCurrent
70518-2455-47051824550450 in 1 BOTTLE, PLASTICHistorical