FDA.reportPublic FDA data

Pitavastatin

Product NDC
65162-031
11-digit product format
651620031
Labeler code
65162
Product ID
65162-031_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
4 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205961-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2024-08-20
A205961-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2024-08-20
A205961-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2024-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A205961-001AB
A205961-002AB
A205961-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205961-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2024-08-20a50c72e98297…
2026-08-01 22:54:322026-06A205961-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2024-08-20a50c72e98297…
2026-08-01 22:54:322026-06A205961-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2024-08-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205961-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205961-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205961-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PitavastatinPITAVASTATINAmneal Pharmaceuticals LLC7fbfcc0c-9251-456d-a525-e62cfd8abd4b2024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205961
application number: ANDA205961
ndc (product): 65162-031

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN CALCIUM4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IYD54XEG3WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861643Internal RxNorm lookup
861648Internal RxNorm lookup
861652Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fbfcc0c-9251-456d-a525-e62cfd8abd4bAvailable on FDA.report

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
65162-031-03Pitavastatin30 in 1 BOTTLETABLET, FILM COATED3012
65162-031-09Pitavastatin90 in 1 BOTTLETABLET, FILM COATED9012
65162-031-50Pitavastatin500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-031-09EA - Each65162-031430633c9-17d3-4168-ba5b-4143e9d15e6712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-031PITAVASTATIN 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
65162-031-036516200310330 TABLET, FILM COATED in 1 BOTTLE (65162-031-03) 2024-08-21NoNoCurrent
65162-031-096516200310990 TABLET, FILM COATED in 1 BOTTLE (65162-031-09) 2024-08-21NoNoCurrent
65162-031-5065162003150500 TABLET, FILM COATED in 1 BOTTLE (65162-031-50) 2024-08-21NoNoCurrent