FDA.reportPublic FDA data

VALACYCLOVIR HYDROCHLORIDE

Product NDC
72189-037
11-digit product format
721890037
Labeler code
72189
Product ID
72189-037_dc9cd06b-42af-02cf-e053-2995a90ab2fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA201506
Marketing category
ANDA
Marketing start
2019-11-18
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
72189-037-212025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE
72189-037-302025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE
72189-037-602025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE
72189-037-902025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-037-21VALACYCLOVIR HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED218
72189-037-30VALACYCLOVIR HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
72189-037-60VALACYCLOVIR HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED608
72189-037-90VALACYCLOVIR HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-037-21EA - Each72189-037e7656e8e-1909-41f2-99e0-b92b7906e2c012019-12-10
72189-037-30EA - Each72189-037758120bf-dc90-4c4b-b011-bf4af93344a912020-07-13
72189-037-60EA - Each72189-03769ee8cfa-0b31-4525-9fe2-5221f796b4a612020-07-13
72189-037-90EA - Each72189-037519c00a8-51fe-4b33-a22d-3ccd39d6a53f12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-037ACYCLOVIR TABLET VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED VALACYCLOVIR TABLET, FILM COATED [DIRECT RX]8Legacy NDC, 4 package rows20230630_97a10bb6-52c0-495d-e053-2995a90a60a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-037-217218900372121 TABLET, FILM COATED in 1 BOTTLE (72189-037-21) 2019-11-180000-00-00NoNoCurrent
72189-037-307218900373030 TABLET, FILM COATED in 1 BOTTLE (72189-037-30) 2019-11-180000-00-00NoNoCurrent
72189-037-607218900376060 TABLET, FILM COATED in 1 BOTTLE (72189-037-60) 2019-11-180000-00-00NoNoCurrent
72189-037-907218900379090 TABLET, FILM COATED in 1 BOTTLE (72189-037-90) 2019-11-180000-00-00NoNoCurrent