FDA.reportPublic FDA data

Valacyclovir

Product NDC
31722-705
11-digit product format
317220705
Labeler code
31722
Product ID
31722-705_461ff6f2-7bf1-82fb-e063-6294a90acb06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/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
Valacyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564, 313565

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
31722-705-01Valacyclovir100 in 1 BOTTLETABLET, FILM COATED1005
31722-705-05Valacyclovir500 in 1 BOTTLETABLET, FILM COATED5005
31722-705-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED305
31722-705-60Valacyclovir60 in 1 BOTTLETABLET, FILM COATED605
31722-705-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-705VALACYCLOVIR (VALACYCLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20240316_7f5e96e0-534c-47a5-bb79-926088afc73c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN69301126-c901-4d0d-9acb-91ba1a87cd2133
313565valACYclovir 500 MG Oral TabletPSN69301126-c901-4d0d-9acb-91ba1a87cd2133
313564valacyclovir 1000 MG Oral TabletSCD69301126-c901-4d0d-9acb-91ba1a87cd2133
313565valacyclovir 500 MG Oral TabletSCD69301126-c901-4d0d-9acb-91ba1a87cd2133
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY69301126-c901-4d0d-9acb-91ba1a87cd2133
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY69301126-c901-4d0d-9acb-91ba1a87cd2133
313564valacyclovir 1 GM Oral TabletSY69301126-c901-4d0d-9acb-91ba1a87cd2133
313564valACYclovir 1 GM Oral TabletPSN1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir 1000 MG Oral TabletSCD1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir 1 GM Oral TabletSY1b11361c-5444-498b-ab7c-fbad917705ae21
313564valACYclovir 1 GM Oral TabletPSN7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1000 MG Oral TabletSCD7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614
313564valACYclovir 1 GM Oral TabletPSNe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir 1000 MG Oral TabletSCDe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir 1 GM Oral TabletSYe5f5223f-569c-40c6-a3c7-381bc61cf8c69
197313acyclovir 800 MG Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
313564valACYclovir 1 GM Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
197313acyclovir 800 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1000 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
197313acycycloguanosine 800 MG Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valACYclovir 1 GM Oral TabletPSNa5030b9d-1adb-f474-e053-2995a90ae0a07
313564valACYclovir 1 GM Oral TabletPSN7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valACYclovir 1 GM Oral TabletPSNe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir 1000 MG Oral TabletSCD7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valacyclovir 1000 MG Oral TabletSCDe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir 1000 MG Oral TabletSCDa5030b9d-1adb-f474-e053-2995a90ae0a07
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa5030b9d-1adb-f474-e053-2995a90ae0a07
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valacyclovir 1 GM Oral TabletSYa5030b9d-1adb-f474-e053-2995a90ae0a07
313564valacyclovir 1 GM Oral TabletSYe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir 1 GM Oral TabletSY7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valACYclovir 1 GM Oral TabletPSN8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir 1000 MG Oral TabletSCD8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir 1 GM Oral TabletSY8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valACYclovir 1 GM Oral TabletPSN84601168-8829-f4a3-e053-2991aa0a3c205
313564valACYclovir 1 GM Oral TabletPSN7f5e96e0-534c-47a5-bb79-926088afc73c5
313565valACYclovir 500 MG Oral TabletPSN7f5e96e0-534c-47a5-bb79-926088afc73c5
313564valacyclovir 1000 MG Oral TabletSCD84601168-8829-f4a3-e053-2991aa0a3c205
313564valacyclovir 1000 MG Oral TabletSCD7f5e96e0-534c-47a5-bb79-926088afc73c5
313565valacyclovir 500 MG Oral TabletSCD7f5e96e0-534c-47a5-bb79-926088afc73c5
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY84601168-8829-f4a3-e053-2991aa0a3c205
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7f5e96e0-534c-47a5-bb79-926088afc73c5
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY7f5e96e0-534c-47a5-bb79-926088afc73c5
313564valacyclovir 1 GM Oral TabletSY7f5e96e0-534c-47a5-bb79-926088afc73c5
313564valacyclovir 1 GM Oral TabletSY84601168-8829-f4a3-e053-2991aa0a3c205
313564valACYclovir 1 GM Oral TabletPSN544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir 1000 MG Oral TabletSCD544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir 1 GM Oral TabletSY544eb47f-1622-1773-e054-00144ff8d46c4
313564valACYclovir 1 GM Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valACYclovir 500 MG Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir 1000 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir 500 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valACYclovir 1 GM Oral TabletPSNe0926f25-03fa-7f59-e053-2a95a90a145a1
313564valACYclovir 1 GM Oral TabletPSNbed99bed-3904-5278-e053-2a95a90aeab61
313564valACYclovir 1 GM Oral TabletPSN5100ef9f-6dc2-fa06-e063-6294a90accd01
313564valacyclovir 1000 MG Oral TabletSCDe0926f25-03fa-7f59-e053-2a95a90a145a1
313564valacyclovir 1000 MG Oral TabletSCDbed99bed-3904-5278-e053-2a95a90aeab61
313564valacyclovir 1000 MG Oral TabletSCD5100ef9f-6dc2-fa06-e063-6294a90accd01
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe0926f25-03fa-7f59-e053-2a95a90a145a1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYbed99bed-3904-5278-e053-2a95a90aeab61
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY5100ef9f-6dc2-fa06-e063-6294a90accd01
313564valacyclovir 1 GM Oral TabletSYe0926f25-03fa-7f59-e053-2a95a90a145a1
313564valacyclovir 1 GM Oral TabletSYbed99bed-3904-5278-e053-2a95a90aeab61
313564valacyclovir 1 GM Oral TabletSY5100ef9f-6dc2-fa06-e063-6294a90accd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-705-0131722070501100 TABLET, FILM COATED in 1 BOTTLE (31722-705-01) 2015-05-250000-00-00NoNoCurrent
31722-705-0531722070505500 TABLET, FILM COATED in 1 BOTTLE (31722-705-05) 2015-05-250000-00-00NoNoCurrent
31722-705-303172207053030 TABLET, FILM COATED in 1 BOTTLE (31722-705-30) 2015-05-250000-00-00NoNoCurrent
31722-705-603172207056060 TABLET, FILM COATED in 1 BOTTLE (31722-705-60) 2015-05-250000-00-00NoNoCurrent
31722-705-903172207059090 TABLET, FILM COATED in 1 BOTTLE (31722-705-90) 2015-05-250000-00-00NoNoCurrent