FDA.reportPublic FDA data

Acyclovir

Product NDC
61442-112
11-digit product format
614420112
Labeler code
61442
Product ID
61442-112_209d3251-8d40-86dc-e063-6394a90a3492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311, 197313

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
61442-112-012020-02-02C16284748780-19d75b9cf-e18c-f424-e053-dadaa90a57ceAcyclovir Tablets USP
61442-112-052020-02-02C16284748780-19d75b9cf-e18c-f424-e053-dadaa90a57ceAcyclovir Tablets USP
61442-112-012020-01-31C16284748780-19d75b9cf-e18c-f424-e053-dadaa90a57ceAcyclovir Tablets USP
61442-112-052020-01-31C16284748780-19d75b9cf-e18c-f424-e053-dadaa90a57ceAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-112-01Acyclovir100 in 1 BOTTLE, PLASTICTABLET1009
61442-112-01Acyclovir24 in 1 BOXTABLET249
61442-112-05Acyclovir500 in 1 BOTTLE, PLASTICTABLET5009
61442-112-05Acyclovir12 in 1 BOXTABLET129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-112-01EA - Each61442-112e0416be0-6096-49ce-ae57-042c6395865f12012-07-24
61442-112-05EA - Each61442-11267b1a9eb-4815-428b-ba64-6ebfe577f02312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
Starch, CornINACTIVE INGREDIENTO8232NY3SJACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]4
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
acyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
magnesium stearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]3
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-112ACYCLOVIR TABLET [CARLSBAD TECHNOLOGY, INC.]9Current NDC, Legacy NDC, 4 package rows20240828_a68e610a-841c-4b69-9233-673d060561e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102
197311acyclovir 400 MG Oral TabletSCDf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102
197311acycycloguanosine 400 MG Oral TabletSYf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102
197311acyclovir 400 MG Oral TabletPSN8c5d1f30-2d31-417d-860b-7228b7baaa64101
197311acyclovir 400 MG Oral TabletSCD8c5d1f30-2d31-417d-860b-7228b7baaa64101
197311acycycloguanosine 400 MG Oral TabletSY8c5d1f30-2d31-417d-860b-7228b7baaa64101
197311acyclovir 400 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197313acyclovir 800 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197313acyclovir 800 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acycycloguanosine 400 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197313acycycloguanosine 800 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletPSN5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acyclovir 400 MG Oral TabletPSNa68e610a-841c-4b69-9233-673d060561e89
197313acyclovir 800 MG Oral TabletPSNa68e610a-841c-4b69-9233-673d060561e89
197311acyclovir 400 MG Oral TabletSCD5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acyclovir 400 MG Oral TabletSCDa68e610a-841c-4b69-9233-673d060561e89
197313acyclovir 800 MG Oral TabletSCDa68e610a-841c-4b69-9233-673d060561e89
197311acycycloguanosine 400 MG Oral TabletSY5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acycycloguanosine 400 MG Oral TabletSYa68e610a-841c-4b69-9233-673d060561e89
197313acycycloguanosine 800 MG Oral TabletSYa68e610a-841c-4b69-9233-673d060561e89
197311acyclovir 400 MG Oral TabletPSN785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197311acyclovir 400 MG Oral TabletPSN89583890-186b-4a7a-8741-41f6c5f0a99d8
197313acyclovir 800 MG Oral TabletPSN785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197311acyclovir 400 MG Oral TabletSCD89583890-186b-4a7a-8741-41f6c5f0a99d8
197311acyclovir 400 MG Oral TabletSCD785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197313acyclovir 800 MG Oral TabletSCD785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197311acycycloguanosine 400 MG Oral TabletSY785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197311acycycloguanosine 400 MG Oral TabletSY89583890-186b-4a7a-8741-41f6c5f0a99d8
197313acycycloguanosine 800 MG Oral TabletSY785d68bc-0bbf-b69d-e053-2991aa0ac0d58
197311acyclovir 400 MG Oral TabletPSN33630a35-346e-43b6-9286-89e28ac0094a5
197313acyclovir 800 MG Oral TabletPSN33630a35-346e-43b6-9286-89e28ac0094a5
197311acyclovir 400 MG Oral TabletSCD33630a35-346e-43b6-9286-89e28ac0094a5
197313acyclovir 800 MG Oral TabletSCD33630a35-346e-43b6-9286-89e28ac0094a5
197311acycycloguanosine 400 MG Oral TabletSY33630a35-346e-43b6-9286-89e28ac0094a5
197313acycycloguanosine 800 MG Oral TabletSY33630a35-346e-43b6-9286-89e28ac0094a5
197311acyclovir 400 MG Oral TabletPSNb93432f0-535c-ab31-e053-2a95a90a03a83
197311acyclovir 400 MG Oral TabletPSNbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197313acyclovir 800 MG Oral TabletPSNbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acyclovir 400 MG Oral TabletSCDb93432f0-535c-ab31-e053-2a95a90a03a83
197311acyclovir 400 MG Oral TabletSCDbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197313acyclovir 800 MG Oral TabletSCDbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acycycloguanosine 400 MG Oral TabletSYbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acycycloguanosine 400 MG Oral TabletSYb93432f0-535c-ab31-e053-2a95a90a03a83
197313acycycloguanosine 800 MG Oral TabletSYbf1e7864-07c5-4c2c-a075-fad00612ee2a3
197311acyclovir 400 MG Oral TabletPSNc46d5033-b1b2-e213-e053-2995a90ae6a32
197311acyclovir 400 MG Oral TabletSCDc46d5033-b1b2-e213-e053-2995a90ae6a32
197311acycycloguanosine 400 MG Oral TabletSYc46d5033-b1b2-e213-e053-2995a90ae6a32
197311acyclovir 400 MG Oral TabletPSNa91f3431-fb3f-4c78-b1db-e374104c3f8d1
197311acyclovir 400 MG Oral TabletPSN6654f203-6465-4089-9c1d-1808b833791a1
197311acyclovir 400 MG Oral TabletSCDa91f3431-fb3f-4c78-b1db-e374104c3f8d1
197311acyclovir 400 MG Oral TabletSCD6654f203-6465-4089-9c1d-1808b833791a1
197311acycycloguanosine 400 MG Oral TabletSYa91f3431-fb3f-4c78-b1db-e374104c3f8d1
197311acycycloguanosine 400 MG Oral TabletSY6654f203-6465-4089-9c1d-1808b833791a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-112-016144201120124 BOTTLE, PLASTIC in 1 BOX (61442-112-01) / 100 TABLET in 1 BOTTLE, PLASTIC2020-01-240000-00-00NoNoCurrent
61442-112-056144201120512 BOTTLE, PLASTIC in 1 BOX (61442-112-05) / 500 TABLET in 1 BOTTLE, PLASTIC2020-01-240000-00-00NoNoCurrent