FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-2408
11-digit product format
680712408
Labeler code
68071
Product ID
68071-2408_4df16506-8ef6-bd4b-e063-6294a90a1195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2408-12023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2408-22023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2408-32023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2408-42023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2408-52023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2408-72023-01-30C16284748780-1f386c649-c18c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2408-1Acyclovir21 in 1 BOTTLE, PLASTICTABLET212
68071-2408-2Acyclovir25 in 1 BOTTLE, PLASTICTABLET252
68071-2408-3Acyclovir30 in 1 BOTTLE, PLASTICTABLET302
68071-2408-4Acyclovir14 in 1 BOTTLE, PLASTICTABLET142
68071-2408-5Acyclovir35 in 1 BOTTLE, PLASTICTABLET352
68071-2408-7Acyclovir15 in 1 BOTTLE, PLASTICTABLET152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2408ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 6 package rows20210522_c2d9940a-ce88-5fd0-e053-2a95a90a4bc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNc2d9940a-ce88-5fd0-e053-2a95a90a4bc82
197313acyclovir 800 MG Oral TabletSCDc2d9940a-ce88-5fd0-e053-2a95a90a4bc82
197313acycycloguanosine 800 MG Oral TabletSYc2d9940a-ce88-5fd0-e053-2a95a90a4bc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2408-16807124080121 TABLET in 1 BOTTLE, PLASTIC (68071-2408-1) 21 tablet2021-05-210000-00-00NoNoCurrent
68071-2408-26807124080225 TABLET in 1 BOTTLE, PLASTIC (68071-2408-2) 25 tablet2021-05-210000-00-00NoNoCurrent
68071-2408-36807124080330 TABLET in 1 BOTTLE, PLASTIC (68071-2408-3) 30 tablet2021-05-210000-00-00NoNoCurrent
68071-2408-46807124080414 TABLET in 1 BOTTLE, PLASTIC (68071-2408-4) 14 tablet2021-05-210000-00-00NoNoCurrent
68071-2408-56807124080535 TABLET in 1 BOTTLE, PLASTIC (68071-2408-5) 35 tablet2021-05-210000-00-00NoNoCurrent
68071-2408-76807124080715 TABLET in 1 BOTTLE, PLASTIC (68071-2408-7) 15 tablet2021-05-210000-00-00NoNoCurrent