FDA.reportPublic FDA data

acyclovir

Product NDC
70518-0427
11-digit product format
705180427
Labeler code
70518
Product ID
70518-0427_47f67704-3da4-510a-e063-6294a90ae0a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077309
Marketing category
ANDA
Marketing start
2017-04-17
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

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
70518-0427-0acyclovir15 in 1 BOTTLE, PLASTICTABLET1519
70518-0427-1acyclovir30 in 1 BOTTLE, PLASTICTABLET3019
70518-0427-2acyclovir21 in 1 BOTTLE, PLASTICTABLET2119
70518-0427-3acyclovir30 in 1 BOTTLE, PLASTICTABLET3019
70518-0427-4acyclovir28 in 1 BOTTLE, PLASTICTABLET2819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0427-1EA - Each70518-0427cc822e04-90b6-46bd-9786-199700a7bcd812023-01-09
70518-0427-3EA - Each70518-04275ccddea8-d7fe-40fd-978b-52b254bd561112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0427ACYCLOVIR TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 5 package rows20250112_499c6a98-0614-4ded-8526-909942bae8a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN499c6a98-0614-4ded-8526-909942bae8a419
197311acyclovir 400 MG Oral TabletSCD499c6a98-0614-4ded-8526-909942bae8a419
197311acycycloguanosine 400 MG Oral TabletSY499c6a98-0614-4ded-8526-909942bae8a419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0427-07051804270015 TABLET in 1 BOTTLE, PLASTIC (70518-0427-0) 15 tablet2017-04-170000-00-00NoNoCurrent
70518-0427-17051804270130 TABLET in 1 BOTTLE, PLASTIC (70518-0427-1) 30 tablet2017-04-212026-12-31NoNoCurrent
70518-0427-27051804270221 TABLET in 1 BOTTLE, PLASTIC (70518-0427-2) 21 tablet2017-04-240000-00-00NoNoCurrent
70518-0427-37051804270330 TABLET in 1 BOTTLE, PLASTIC (70518-0427-3) 30 tablet2021-09-200000-00-00NoNoCurrent
70518-0427-47051804270428 in 1 BOTTLE, PLASTICHistorical