pitavastatin calcium

Product NDC
70771-1784
11-digit product format
707711784
Labeler code
70771
Product ID
70771-1784_e441676b-f28d-4506-9b0e-b8e28b1f7d1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206047
Marketing category
ANDA
Marketing start
2023-11-02
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 calcium
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
70771-1784-9pitavastatin calcium90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1784PITAVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, 1 package rows20241207_7b1a9aa6-a7a4-4050-8a40-89ba9728555a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSN7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861648pitavastatin calcium 2 MG Oral TabletPSN7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861652pitavastatin calcium 4 MG Oral TabletPSN7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861643pitavastatin calcium 1 MG Oral TabletSCD7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861648pitavastatin calcium 2 MG Oral TabletSCD7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861652pitavastatin calcium 4 MG Oral TabletSCD7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY7b1a9aa6-a7a4-4050-8a40-89ba9728555a5
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY7b1a9aa6-a7a4-4050-8a40-89ba9728555a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1784-97077117840990 TABLET in 1 BOTTLE (70771-1784-9) 90 tablet2023-11-02NoNoHistorical