FDA.reportPublic FDA data

Acyclovir

Product NDC
70518-2518
11-digit product format
705182518
Labeler code
70518
Product ID
70518-2518_4a652104-b1e5-e0fb-e063-6394a90a8f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2020-01-01
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
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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197313

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
70518-2518-0Acyclovir30 in 1 BLISTER PACKTABLET3011
70518-2518-1Acyclovir30 in 1 BLISTER PACKTABLET3011
70518-2518-2Acyclovir10 in 1 BOTTLE, PLASTICTABLET1011
70518-2518-3Acyclovir6 in 1 BOTTLE, PLASTICTABLET611
70518-2518-4Acyclovir35 in 1 BOTTLE, PLASTICTABLET3511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2518-0EA - Each70518-25186fe07745-ab6f-4a92-b807-ce84ad285f5612023-01-09
70518-2518-1EA - Each70518-251865dddfcb-aac7-4e40-9133-8fcaa98563fd12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2518ACYCLOVIR TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 5 package rows20250206_736679be-469e-4bdb-8e15-b10751c3dd60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN736679be-469e-4bdb-8e15-b10751c3dd6011
197313acyclovir 800 MG Oral TabletSCD736679be-469e-4bdb-8e15-b10751c3dd6011
197313acycycloguanosine 800 MG Oral TabletSY736679be-469e-4bdb-8e15-b10751c3dd6011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2518-07051825180030 TABLET in 1 BLISTER PACK (70518-2518-0) 30 tablet2020-01-010000-00-00NoNoCurrent
70518-2518-17051825180130 TABLET in 1 BLISTER PACK (70518-2518-1) 30 tablet2020-07-060000-00-00NoNoCurrent
70518-2518-27051825180210 TABLET in 1 BOTTLE, PLASTIC (70518-2518-2) 10 tablet2023-04-12NoNoHistorical
70518-2518-3705182518036 in 1 BOTTLE, PLASTICHistorical
70518-2518-47051825180435 in 1 BOTTLE, PLASTICHistorical