FDA.reportPublic FDA data

Pitavastatin

Product NDC
0832-6049
11-digit product format
008326049
Labeler code
0832
Product ID
0832-6049_266944ba-7e94-48c6-e063-6394a90adc2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pitavastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA205955
Marketing category
ANDA
Marketing start
2023-11-02
Substance
PITAVASTATIN CALCIUM
Active strength
2 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
A205955-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2017-02-03
A205955-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2017-02-03
A205955-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2017-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205955-001AB
A205955-002AB
A205955-003AB

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 22:54:322026-06A205955-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2017-02-03a50c72e98297…
2026-08-01 22:54:322026-06A205955-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2017-02-03a50c72e98297…
2026-08-01 22:54:322026-06A205955-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2017-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205955-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205955-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205955-003AB1a50c72e98297…

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
PitavastatinPITAVASTATIN CALCIUMGolden State Medical Supply, Inc.2d5a1b78-4aa6-537b-e063-6394a90a522f2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205955
application number: ANDA205955
PitavastatinPITAVASTATIN CALCIUMUpsher-Smith Laboratories, LLC9ad1ecb9-822d-47c1-9f6f-6f771fa0f9242026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205955
application number: ANDA205955
ndc (product): 0832-6049

Additional Listing Data#

Finished product
Yes
Brand name base
Pitavastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN CALCIUM2 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
9ad1ecb9-822d-47c1-9f6f-6f771fa0f924Available 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
0832-6049-90Pitavastatin90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-6049PITAVASTATIN (PITAVASTATIN CALCIUM) TABLET [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, 1 package rows20241109_9ad1ecb9-822d-47c1-9f6f-6f771fa0f924.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSN9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861648pitavastatin calcium 2 MG Oral TabletPSN9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861652pitavastatin calcium 4 MG Oral TabletPSN9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861643pitavastatin calcium 1 MG Oral TabletSCD9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861648pitavastatin calcium 2 MG Oral TabletSCD9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861652pitavastatin calcium 4 MG Oral TabletSCD9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY9ad1ecb9-822d-47c1-9f6f-6f771fa0f9247
861643pitavastatin calcium 1 MG Oral TabletPSN2d5a1b78-4aa6-537b-e063-6394a90a522f1
861648pitavastatin calcium 2 MG Oral TabletPSN2d5a1b78-4aa6-537b-e063-6394a90a522f1
861652pitavastatin calcium 4 MG Oral TabletPSN2d5a1b78-4aa6-537b-e063-6394a90a522f1
861643pitavastatin calcium 1 MG Oral TabletSCD2d5a1b78-4aa6-537b-e063-6394a90a522f1
861648pitavastatin calcium 2 MG Oral TabletSCD2d5a1b78-4aa6-537b-e063-6394a90a522f1
861652pitavastatin calcium 4 MG Oral TabletSCD2d5a1b78-4aa6-537b-e063-6394a90a522f1
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSY2d5a1b78-4aa6-537b-e063-6394a90a522f1
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSY2d5a1b78-4aa6-537b-e063-6394a90a522f1
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSY2d5a1b78-4aa6-537b-e063-6394a90a522f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0832-6049-900083260499090 TABLET in 1 BOTTLE (0832-6049-90) 90 tablet2023-11-02NoNoCurrent