FDA.reportPublic FDA data

Pitavastatin

Product NDC
65162-029
11-digit product format
651620029
Labeler code
65162
Product ID
65162-029_ab7d1d71-229c-4528-9c2d-59d268c48c25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pitavastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205961
Marketing category
ANDA
Marketing start
2024-08-21
Substance
PITAVASTATIN CALCIUM
Active strength
1 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 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
de94155c-7345-40be-9a5b-89d04e1ac565Product name120190313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-029-03Pitavastatin30 in 1 BOTTLETABLET, FILM COATED3012
65162-029-09Pitavastatin90 in 1 BOTTLETABLET, FILM COATED9012
65162-029-50Pitavastatin500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-029-09EA - Each65162-029be74d503-474d-438d-86ed-9c2d3563589512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-029PITAVASTATIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]12Current NDC, 3 package rows20240825_7fbfcc0c-9251-456d-a525-e62cfd8abd4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSN7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861648pitavastatin calcium 2 MG Oral TabletPSN7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861652pitavastatin calcium 4 MG Oral TabletPSN7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861643pitavastatin calcium 1 MG Oral TabletSCD7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861648pitavastatin calcium 2 MG Oral TabletSCD7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861652pitavastatin calcium 4 MG Oral TabletSCD7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY7fbfcc0c-9251-456d-a525-e62cfd8abd4b12
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY7fbfcc0c-9251-456d-a525-e62cfd8abd4b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65162-029-036516200290330 TABLET, FILM COATED in 1 BOTTLE (65162-029-03) 2024-08-21NoNoHistorical
65162-029-096516200290990 TABLET, FILM COATED in 1 BOTTLE (65162-029-09) 2024-08-21NoNoHistorical
65162-029-5065162002950500 TABLET, FILM COATED in 1 BOTTLE (65162-029-50) 2024-08-21NoNoHistorical