FDA.reportPublic FDA data

Acyclovir

Product NDC
31722-777
11-digit product format
317220777
Labeler code
31722
Product ID
31722-777_49d4285f-03ac-75ae-e063-6294a90a0da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-777-01Acyclovir100 in 1 BOTTLETABLET1004
31722-777-05Acyclovir500 in 1 BOTTLETABLET5004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [PROFICIENT RX LP]2
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [DIRECTRX]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [PROFICIENT RX LP]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [DIRECTRX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACYCLOVIR TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACYCLOVIR TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [PROFICIENT RX LP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACYCLOVIR TABLET [DIRECTRX]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACYCLOVIR TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [DIRECTRX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [PROFICIENT RX LP]2
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-777ACYCLOVIR (ACYCLOVIR) TABLET [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20210407_0910335b-6796-459f-b97e-d7ef5439a060.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019
197311acyclovir 400 MG Oral TabletSCDdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019
197311acycycloguanosine 400 MG Oral TabletSYdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019
197311acyclovir 400 MG Oral TabletPSN6d0e492e-5359-49e8-812d-8c8e2e5d42f815
197311acyclovir 400 MG Oral TabletSCD6d0e492e-5359-49e8-812d-8c8e2e5d42f815
197311acycycloguanosine 400 MG Oral TabletSY6d0e492e-5359-49e8-812d-8c8e2e5d42f815
197311acyclovir 400 MG Oral TabletPSN38547daa-7d2f-4a7b-84d3-6e164984f95810
197311acyclovir 400 MG Oral TabletSCD38547daa-7d2f-4a7b-84d3-6e164984f95810
197311acycycloguanosine 400 MG Oral TabletSY38547daa-7d2f-4a7b-84d3-6e164984f95810
197311acyclovir 400 MG Oral TabletPSNc55bde35-a202-4c25-b545-e5d5e95c11758
197311acyclovir 400 MG Oral TabletPSN0e78d5e8-ae2d-4e84-b8c2-6765b1299c128
197311acyclovir 400 MG Oral TabletSCDc55bde35-a202-4c25-b545-e5d5e95c11758
197311acyclovir 400 MG Oral TabletSCD0e78d5e8-ae2d-4e84-b8c2-6765b1299c128
197311acycycloguanosine 400 MG Oral TabletSYc55bde35-a202-4c25-b545-e5d5e95c11758
197311acycycloguanosine 400 MG Oral TabletSY0e78d5e8-ae2d-4e84-b8c2-6765b1299c128
197311acyclovir 400 MG Oral TabletPSN5dcfd21c-43f0-469c-be70-a4e74e6ccf887
197311acyclovir 400 MG Oral TabletSCD5dcfd21c-43f0-469c-be70-a4e74e6ccf887
197311acycycloguanosine 400 MG Oral TabletSY5dcfd21c-43f0-469c-be70-a4e74e6ccf887
197311acyclovir 400 MG Oral TabletPSN83e82707-85b6-2fea-e053-2991aa0a99ef4
197311acyclovir 400 MG Oral TabletPSN0910335b-6796-459f-b97e-d7ef5439a0604
197311acyclovir 400 MG Oral TabletPSN638803d2-a172-486d-e053-2991aa0ab0744
197313acyclovir 800 MG Oral TabletPSN0910335b-6796-459f-b97e-d7ef5439a0604
197311acyclovir 400 MG Oral TabletSCD83e82707-85b6-2fea-e053-2991aa0a99ef4
197311acyclovir 400 MG Oral TabletSCD638803d2-a172-486d-e053-2991aa0ab0744
197311acyclovir 400 MG Oral TabletSCD0910335b-6796-459f-b97e-d7ef5439a0604
197313acyclovir 800 MG Oral TabletSCD0910335b-6796-459f-b97e-d7ef5439a0604
197311acycycloguanosine 400 MG Oral TabletSY83e82707-85b6-2fea-e053-2991aa0a99ef4
197311acycycloguanosine 400 MG Oral TabletSY638803d2-a172-486d-e053-2991aa0ab0744
197311acycycloguanosine 400 MG Oral TabletSY0910335b-6796-459f-b97e-d7ef5439a0604
197313acycycloguanosine 800 MG Oral TabletSY0910335b-6796-459f-b97e-d7ef5439a0604
197311acyclovir 400 MG Oral TabletPSN4e7965f2-09ba-6f9a-e054-00144ff8d46c3
197311acyclovir 400 MG Oral TabletSCD4e7965f2-09ba-6f9a-e054-00144ff8d46c3
197311acycycloguanosine 400 MG Oral TabletSY4e7965f2-09ba-6f9a-e054-00144ff8d46c3
197311acyclovir 400 MG Oral TabletPSN90de5561-77a1-445b-999d-2a43b1a1bb552
197311acyclovir 400 MG Oral TabletPSN96fcc438-fc47-456c-bf31-6df278b122442
197311acyclovir 400 MG Oral TabletPSN8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acyclovir 400 MG Oral TabletPSNf4c5779d-e4bf-4f2b-e053-2995a90a91872
197311acyclovir 400 MG Oral TabletPSN46150f19-ce5d-42a0-80a7-f96fda2b98792
197311acyclovir 400 MG Oral TabletSCD96fcc438-fc47-456c-bf31-6df278b122442
197311acyclovir 400 MG Oral TabletSCDf4c5779d-e4bf-4f2b-e053-2995a90a91872
197311acyclovir 400 MG Oral TabletSCD90de5561-77a1-445b-999d-2a43b1a1bb552
197311acyclovir 400 MG Oral TabletSCD8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acyclovir 400 MG Oral TabletSCD46150f19-ce5d-42a0-80a7-f96fda2b98792
197311acycycloguanosine 400 MG Oral TabletSYf4c5779d-e4bf-4f2b-e053-2995a90a91872
197311acycycloguanosine 400 MG Oral TabletSY96fcc438-fc47-456c-bf31-6df278b122442
197311acycycloguanosine 400 MG Oral TabletSY90de5561-77a1-445b-999d-2a43b1a1bb552
197311acycycloguanosine 400 MG Oral TabletSY8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acycycloguanosine 400 MG Oral TabletSY46150f19-ce5d-42a0-80a7-f96fda2b98792
197311acyclovir 400 MG Oral TabletPSNa8524172-91fb-6eb2-e053-2a95a90a1cae1
197311acyclovir 400 MG Oral TabletPSNe4f91376-9e18-41a4-aa5e-adcea0c625d91
197311acyclovir 400 MG Oral TabletPSN0514f788-1b06-9239-e063-6294a90a8ac21
197311acyclovir 400 MG Oral TabletSCDa8524172-91fb-6eb2-e053-2a95a90a1cae1
197311acyclovir 400 MG Oral TabletSCDe4f91376-9e18-41a4-aa5e-adcea0c625d91
197311acyclovir 400 MG Oral TabletSCD0514f788-1b06-9239-e063-6294a90a8ac21
197311acycycloguanosine 400 MG Oral TabletSYa8524172-91fb-6eb2-e053-2a95a90a1cae1
197311acycycloguanosine 400 MG Oral TabletSYe4f91376-9e18-41a4-aa5e-adcea0c625d91
197311acycycloguanosine 400 MG Oral TabletSY0514f788-1b06-9239-e063-6294a90a8ac21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-777-0131722077701100 TABLET in 1 BOTTLE (31722-777-01) 100 tablet2013-11-290000-00-00NoNoCurrent
31722-777-0531722077705500 TABLET in 1 BOTTLE (31722-777-05) 500 tablet2013-11-290000-00-00NoNoCurrent