Livalo

Product NDC
66869-404
11-digit product format
668690404
Labeler code
66869
Product ID
66869-404_f558f406-3b8e-4a4b-a817-2fb2e624c79c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kowa Pharmaceuticals America, Inc.
Application
NDA022363
Marketing category
NDA
Marketing start
2019-05-16
Substance
PITAVASTATIN CALCIUM
Active strength
4.18 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Livalo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN CALCIUM4.18 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIYD54XEG3W
Rxcui861643, 861646, 861648, 861650, 861652, 861654

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3b6a39e-87bf-f126-1bde-83d69cbf558bProduct name320250219
de94155c-7345-40be-9a5b-89d04e1ac565Product name120190313

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66869-404-07Livalo7 in 1 CARTONTABLET, FILM COATED711
66869-404-90Livalo90 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66869-404LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC.]10Current NDC, Legacy NDC, 2 package rows20240906_44dcbf97-99ec-427c-ba50-207e0069d6d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861646Livalo 1 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861650Livalo 2 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861654Livalo 4 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861643pitavastatin calcium 1 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861648pitavastatin calcium 2 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861652pitavastatin calcium 4 MG Oral TabletPSN44dcbf97-99ec-427c-ba50-207e0069d6d211
861646pitavastatin calcium 1 MG Oral Tablet [Livalo]SBD44dcbf97-99ec-427c-ba50-207e0069d6d211
861650pitavastatin calcium 2 MG Oral Tablet [Livalo]SBD44dcbf97-99ec-427c-ba50-207e0069d6d211
861654pitavastatin calcium 4 MG Oral Tablet [Livalo]SBD44dcbf97-99ec-427c-ba50-207e0069d6d211
861643pitavastatin calcium 1 MG Oral TabletSCD44dcbf97-99ec-427c-ba50-207e0069d6d211
861648pitavastatin calcium 2 MG Oral TabletSCD44dcbf97-99ec-427c-ba50-207e0069d6d211
861652pitavastatin calcium 4 MG Oral TabletSCD44dcbf97-99ec-427c-ba50-207e0069d6d211
861646Livalo 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861646Livalo 1 MG Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861650Livalo 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861650Livalo 2 MG Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861654Livalo 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861654Livalo 4 MG Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY44dcbf97-99ec-427c-ba50-207e0069d6d211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66869-404-07668690404077 TABLET, FILM COATED in 1 CARTON (66869-404-07) 2019-05-160000-00-00NoNoCurrent
66869-404-906686904049090 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90) 2019-05-160000-00-00NoNoCurrent