FDA.reportPublic FDA data

Valacyclovir

Product NDC
31722-704
11-digit product format
317220704
Labeler code
31722
Product ID
31722-704_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
500 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
Valacyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/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
31722-704-01Valacyclovir100 in 1 BOTTLETABLET, FILM COATED1005
31722-704-05Valacyclovir500 in 1 BOTTLETABLET, FILM COATED5005
31722-704-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED305
31722-704-31Valacyclovir10 in 1 BLISTER PACKTABLET, FILM COATED105
31722-704-32Valacyclovir10 in 1 BLISTER PACKTABLET, FILM COATED105
31722-704-60Valacyclovir60 in 1 BOTTLETABLET, FILM COATED605
31722-704-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-704VALACYCLOVIR (VALACYCLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 7 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 TabletPSN7f5e96e0-534c-47a5-bb79-926088afc73c5
313565valACYclovir 500 MG Oral TabletPSN7f5e96e0-534c-47a5-bb79-926088afc73c5
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 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
313565valACYclovir 500 MG Oral TabletPSN4ab809f3-8898-463c-b55a-f452c87d07794
313565valacyclovir 500 MG Oral TabletSCD4ab809f3-8898-463c-b55a-f452c87d07794
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY4ab809f3-8898-463c-b55a-f452c87d07794
313564valACYclovir 1 GM Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valACYclovir 500 MG Oral TabletPSN6d6d1d4f-c2c1-39f5-e053-2991aa0a107a3
313565valACYclovir 500 MG Oral TabletPSN90a67c02-edce-44aa-8d3a-d819313acc263
313565valACYclovir 500 MG Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir 1000 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir 500 MG Oral TabletSCD6d6d1d4f-c2c1-39f5-e053-2991aa0a107a3
313565valacyclovir 500 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir 500 MG Oral TabletSCD90a67c02-edce-44aa-8d3a-d819313acc263
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY6d6d1d4f-c2c1-39f5-e053-2991aa0a107a3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY90a67c02-edce-44aa-8d3a-d819313acc263
313564valacyclovir 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valACYclovir 500 MG Oral TabletPSN296c04dc-2c64-4784-e063-6294a90ae6a32
313565valACYclovir 500 MG Oral TabletPSN29a6b4ec-3e23-289b-e063-6394a90a11572
313565valacyclovir 500 MG Oral TabletSCD296c04dc-2c64-4784-e063-6294a90ae6a32
313565valacyclovir 500 MG Oral TabletSCD29a6b4ec-3e23-289b-e063-6394a90a11572
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY296c04dc-2c64-4784-e063-6294a90ae6a32
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY29a6b4ec-3e23-289b-e063-6394a90a11572
313565valACYclovir 500 MG Oral TabletPSN2c2d5cec-038f-42bb-8f04-90d2431dc1c91
313565valACYclovir 500 MG Oral TabletPSN3aff1f5e-d92b-686b-e063-6294a90a29951
313565valACYclovir 500 MG Oral TabletPSN50237c2d-99e8-9899-e063-6394a90a468c1
313565valacyclovir 500 MG Oral TabletSCD2c2d5cec-038f-42bb-8f04-90d2431dc1c91
313565valacyclovir 500 MG Oral TabletSCD3aff1f5e-d92b-686b-e063-6294a90a29951
313565valacyclovir 500 MG Oral TabletSCD50237c2d-99e8-9899-e063-6394a90a468c1
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY2c2d5cec-038f-42bb-8f04-90d2431dc1c91
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY3aff1f5e-d92b-686b-e063-6294a90a29951
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY50237c2d-99e8-9899-e063-6394a90a468c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-704-0131722070401100 TABLET, FILM COATED in 1 BOTTLE (31722-704-01) 2015-05-250000-00-00NoNoCurrent
31722-704-0531722070405500 TABLET, FILM COATED in 1 BOTTLE (31722-704-05) 2015-05-250000-00-00NoNoCurrent
31722-704-303172207043030 TABLET, FILM COATED in 1 BOTTLE (31722-704-30) 2015-05-250000-00-00NoNoCurrent
31722-704-313172207043110 TABLET, FILM COATED in 1 BLISTER PACK (31722-704-31) 2015-05-250000-00-00NoNoCurrent
31722-704-323172207043210 TABLET, FILM COATED in 1 BLISTER PACK (31722-704-32) 2015-05-250000-00-00NoNoCurrent
31722-704-603172207046060 TABLET, FILM COATED in 1 BOTTLE (31722-704-60) 2015-05-250000-00-00NoNoCurrent
31722-704-903172207049090 TABLET, FILM COATED in 1 BOTTLE (31722-704-90) 2015-05-250000-00-00NoNoCurrent