FDA.reportPublic FDA data

pitavastatin calcium

Product NDC
68382-483
11-digit product format
683820483
Labeler code
68382
Product ID
68382-483_f34ff300-0613-4b94-9fcf-475d6494ea7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206047
Marketing category
ANDA
Marketing start
2023-11-02
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
A206047-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2023-02-22
A206047-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2023-02-22
A206047-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2023-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206047-001AB
A206047-002AB
A206047-003AB

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 22:54:322026-06A206047-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2023-02-22a50c72e98297…
2026-08-01 22:54:322026-06A206047-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2023-02-22a50c72e98297…
2026-08-01 22:54:322026-06A206047-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2023-02-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206047-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206047-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206047-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pitavastatin calciumPITAVASTATIN CALCIUMZydus Lifesciences Limited7b1a9aa6-a7a4-4050-8a40-89ba9728555a2024-12-03Exact identifier
application applno (ANDA): 206047
application number: ANDA206047
pitavastatin calciumPITAVASTATIN CALCIUMZydus Pharmaceuticals USA Inc.c35e747e-10ac-4a76-bce6-187618fc64f92024-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206047
application number: ANDA206047
ndc (product): 68382-483

Additional Listing Data#

Finished product
Yes
Brand name base
pitavastatin calcium
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
c35e747e-10ac-4a76-bce6-187618fc64f9Available 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
68382-483-16pitavastatin calcium90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-483-16EA - Each68382-48336e11506-2bfc-468e-9dd3-3097b21d95df12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-483PITAVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, 1 package rows20240329_c35e747e-10ac-4a76-bce6-187618fc64f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSNc35e747e-10ac-4a76-bce6-187618fc64f95
861648pitavastatin calcium 2 MG Oral TabletPSNc35e747e-10ac-4a76-bce6-187618fc64f95
861652pitavastatin calcium 4 MG Oral TabletPSNc35e747e-10ac-4a76-bce6-187618fc64f95
861643pitavastatin calcium 1 MG Oral TabletSCDc35e747e-10ac-4a76-bce6-187618fc64f95
861648pitavastatin calcium 2 MG Oral TabletSCDc35e747e-10ac-4a76-bce6-187618fc64f95
861652pitavastatin calcium 4 MG Oral TabletSCDc35e747e-10ac-4a76-bce6-187618fc64f95
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSYc35e747e-10ac-4a76-bce6-187618fc64f95
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSYc35e747e-10ac-4a76-bce6-187618fc64f95
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSYc35e747e-10ac-4a76-bce6-187618fc64f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-483-166838204831690 TABLET in 1 BOTTLE (68382-483-16) 90 tablet2023-11-02NoNoCurrent