FDA.reportPublic FDA data

Pitavastatin

Product NDC
0480-3631
11-digit product format
004803631
Labeler code
0480
Product ID
0480-3631_191b4856-1662-a7b8-e063-6394a90a2c56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA205932
Marketing category
ANDA
Marketing start
2023-11-02
Substance
PITAVASTATIN CALCIUM
Active strength
1.045 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pitavastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN CALCIUM1.045 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIYD54XEG3W
Rxcui861643, 861648, 861652

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3b6a39e-87bf-f126-1bde-83d69cbf558bProduct name320250219
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
de94155c-7345-40be-9a5b-89d04e1ac565Product name120190313
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3631-98Pitavastatin90 in 1 BOTTLETABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3631-98EA - Each0480-363157877afc-80a5-42a4-a77b-9f6b5e5e0ead12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3631PITAVASTATIN (PITAVASTATIN CALCIUM) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]25Current NDC, 1 package rows20250306_fac09182-dcf2-1770-e053-6394a90af50c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSNfac09182-dcf2-1770-e053-6394a90af50c25
861648pitavastatin calcium 2 MG Oral TabletPSNfac09182-dcf2-1770-e053-6394a90af50c25
861652pitavastatin calcium 4 MG Oral TabletPSNfac09182-dcf2-1770-e053-6394a90af50c25
861643pitavastatin calcium 1 MG Oral TabletSCDfac09182-dcf2-1770-e053-6394a90af50c25
861648pitavastatin calcium 2 MG Oral TabletSCDfac09182-dcf2-1770-e053-6394a90af50c25
861652pitavastatin calcium 4 MG Oral TabletSCDfac09182-dcf2-1770-e053-6394a90af50c25
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSYfac09182-dcf2-1770-e053-6394a90af50c25
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSYfac09182-dcf2-1770-e053-6394a90af50c25
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSYfac09182-dcf2-1770-e053-6394a90af50c25
861643pitavastatin calcium 1 MG Oral TabletPSN0f11ee80-871e-4f13-e063-6394a90af19d2
861648pitavastatin calcium 2 MG Oral TabletPSN0f11ee80-871e-4f13-e063-6394a90af19d2
861652pitavastatin calcium 4 MG Oral TabletPSN0f11ee80-871e-4f13-e063-6394a90af19d2
861643pitavastatin calcium 1 MG Oral TabletSCD0f11ee80-871e-4f13-e063-6394a90af19d2
861648pitavastatin calcium 2 MG Oral TabletSCD0f11ee80-871e-4f13-e063-6394a90af19d2
861652pitavastatin calcium 4 MG Oral TabletSCD0f11ee80-871e-4f13-e063-6394a90af19d2
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY0f11ee80-871e-4f13-e063-6394a90af19d2
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY0f11ee80-871e-4f13-e063-6394a90af19d2
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY0f11ee80-871e-4f13-e063-6394a90af19d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-3631-980048036319890 TABLET, FILM COATED in 1 BOTTLE (0480-3631-98) 2023-11-02NoNoHistorical