FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-3222
11-digit product format
680713222
Labeler code
68071
Product ID
68071-3222_1cc108f1-2752-1fed-e063-6394a90a7e9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

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
68071-3222-12023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-22023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-32023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-42023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-52023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-72023-03-10C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-12023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-22023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-32023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-42023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-52023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-72023-01-30C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-12021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-22021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-32021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-42021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-52021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-72021-02-11C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-12021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-22021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-32021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-42021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-52021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-3222-72021-01-29C16284748780-1ba0f9c33-25b4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3222-0Acyclovir50 in 1 BOTTLETABLET505
68071-3222-1Acyclovir21 in 1 BOTTLETABLET215
68071-3222-2Acyclovir25 in 1 BOTTLETABLET255
68071-3222-3Acyclovir30 in 1 BOTTLETABLET305
68071-3222-4Acyclovir14 in 1 BOTTLETABLET145
68071-3222-5Acyclovir35 in 1 BOTTLETABLET355
68071-3222-7Acyclovir15 in 1 BOTTLETABLET155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3222ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 7 package rows20240709_5176c7f9-9076-4797-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN5176c7f9-9076-4797-e054-00144ff8d46c5
197313acyclovir 800 MG Oral TabletSCD5176c7f9-9076-4797-e054-00144ff8d46c5
197313acycycloguanosine 800 MG Oral TabletSY5176c7f9-9076-4797-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3222-06807132220050 TABLET in 1 BOTTLE (68071-3222-0) 50 tablet2017-06-08NoNoCurrent
68071-3222-16807132220121 TABLET in 1 BOTTLE (68071-3222-1) 21 tablet2017-06-080000-00-00NoNoCurrent
68071-3222-26807132220225 TABLET in 1 BOTTLE (68071-3222-2) 25 tablet2017-06-080000-00-00NoNoCurrent
68071-3222-36807132220330 TABLET in 1 BOTTLE (68071-3222-3) 30 tablet2017-06-080000-00-00NoNoCurrent
68071-3222-46807132220414 TABLET in 1 BOTTLE (68071-3222-4) 14 tablet2017-06-080000-00-00NoNoCurrent
68071-3222-56807132220535 TABLET in 1 BOTTLE (68071-3222-5) 35 tablet2017-06-080000-00-00NoNoCurrent
68071-3222-76807132220715 TABLET in 1 BOTTLE (68071-3222-7) 15 tablet2017-06-080000-00-00NoNoCurrent