FDA.reportPublic FDA data

Pitavastatin Calcium

Product NDC
0378-5055
11-digit product format
003785055
Labeler code
0378
Product ID
0378-5055_44bb6612-917c-4457-952a-5751ea607867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206070
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

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
A206070-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2019-04-04
A206070-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2019-04-04
A206070-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2019-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206070-001AB
A206070-002AB
A206070-003AB

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 22:54:322026-06A206070-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2019-04-04a50c72e98297…
2026-08-01 22:54:322026-06A206070-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2019-04-04a50c72e98297…
2026-08-01 22:54:322026-06A206070-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2019-04-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206070-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206070-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206070-003AB1a50c72e98297…

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
Pitavastatin CalciumPITAVASTATINMylan Pharmaceuticals Inc.26b5e5e8-45cd-4a98-9af4-2d04c11308812024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206070
application number: ANDA206070
ndc (product): 0378-5055

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 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
26b5e5e8-45cd-4a98-9af4-2d04c1130881Available on FDA.report

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
0378-5055-77Pitavastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5055-77EA - Each0378-5055ce53f7a0-3a39-411b-8d66-4037354cd9b612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5055PITAVASTATIN CALCIUM (PITAVASTATIN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]5Current NDC, 1 package rows20240828_26b5e5e8-45cd-4a98-9af4-2d04c1130881.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSN26b5e5e8-45cd-4a98-9af4-2d04c11308815
861648pitavastatin calcium 2 MG Oral TabletPSN26b5e5e8-45cd-4a98-9af4-2d04c11308815
861652pitavastatin calcium 4 MG Oral TabletPSN26b5e5e8-45cd-4a98-9af4-2d04c11308815
861643pitavastatin calcium 1 MG Oral TabletSCD26b5e5e8-45cd-4a98-9af4-2d04c11308815
861648pitavastatin calcium 2 MG Oral TabletSCD26b5e5e8-45cd-4a98-9af4-2d04c11308815
861652pitavastatin calcium 4 MG Oral TabletSCD26b5e5e8-45cd-4a98-9af4-2d04c11308815
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY26b5e5e8-45cd-4a98-9af4-2d04c11308815
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY26b5e5e8-45cd-4a98-9af4-2d04c11308815
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY26b5e5e8-45cd-4a98-9af4-2d04c11308815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0378-5055-770037850557790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5055-77) 2023-11-02NoNoCurrent