Valacyclovir hydrochloride

Product NDC
69097-154
11-digit product format
690970154
Labeler code
69097
Product ID
69097-154_b56b9a21-be9f-4ba6-84ca-b08de39b9f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077135
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-154-02EA - Each69097-15439a9950e-3db7-4058-bd33-bb9d1d45623012015-02-02
69097-154-05EA - Each69097-154069d93e3-97c0-463d-ab94-631ec71de10412015-02-02
69097-154-12EA - Each69097-1548a1da214-9843-44ee-b5f4-912c42c2ab8512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82VALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-154VALACYCLOVIR HYDROCHLORIDE TABLET [CIPLA USA INC.]8Legacy NDC20221226_fa2f4056-3503-419d-a1eb-0f2474a61948.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir 1000 MG Oral TabletSCD9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir 1 GM Oral TabletSY9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valACYclovir 1 GM Oral TabletPSN3331ed10-1d2b-4c88-ad2d-881f7f4761983
313565valACYclovir 500 MG Oral TabletPSN3331ed10-1d2b-4c88-ad2d-881f7f4761983
313564valacyclovir 1000 MG Oral TabletSCD3331ed10-1d2b-4c88-ad2d-881f7f4761983
313565valacyclovir 500 MG Oral TabletSCD3331ed10-1d2b-4c88-ad2d-881f7f4761983
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY3331ed10-1d2b-4c88-ad2d-881f7f4761983
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY3331ed10-1d2b-4c88-ad2d-881f7f4761983
313564valacyclovir 1 GM Oral TabletSY3331ed10-1d2b-4c88-ad2d-881f7f4761983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-154-026909701540230 TABLET in 1 BOTTLE (69097-154-02) 30 tablet2010-05-240000-00-00NoNoCurrent
69097-154-056909701540590 TABLET in 1 BOTTLE (69097-154-05) 90 tablet2010-05-240000-00-00NoNoCurrent
69097-154-1269097015412500 TABLET in 1 BOTTLE (69097-154-12) 500 tablet2010-05-240000-00-00NoNoCurrent