FDA.reportPublic FDA data

pitavastatin calcium

Product NDC
31722-876
11-digit product format
317220876
Labeler code
31722
Product ID
31722-876_179e2267-daf5-1cab-e063-6394a90a7f0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pitavastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205977
Marketing category
ANDA
Marketing start
2024-04-30
Substance
PITAVASTATIN CALCIUM
Active strength
2.09 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
A205977-001PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2024-04-30
A205977-002PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2024-04-30
A205977-003PITAVASTATIN CALCIUMPITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2024-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205977-001AB
A205977-002AB
A205977-003AB

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 22:54:322026-06A205977-001PITAVASTATIN CALCIUMEQ 1MG BASETABLET / ORALAB2024-04-30a50c72e98297…
2026-08-01 22:54:322026-06A205977-002PITAVASTATIN CALCIUMEQ 2MG BASETABLET / ORALAB2024-04-30a50c72e98297…
2026-08-01 22:54:322026-06A205977-003PITAVASTATIN CALCIUMEQ 4MG BASETABLET / ORALAB2024-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205977-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205977-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205977-003AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pitavastatin calciumPITAVASTATIN CALCIUMXLCare Pharmaceuticals Inc.f29ea90c-f4e5-4f14-9660-a0404ef87f182025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205977
application number: ANDA205977
pitavastatin calciumPITAVASTATIN CALCIUMNorthStar RxLLC98e3f1df-5b38-4169-a340-adb145eac4592024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205977
application number: ANDA205977
pitavastatin calciumPITAVASTATIN CALCIUMCamber Pharmaceuticals, Inc.e9622824-cee5-49d7-9273-f18b9cc176fd2024-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205977
application number: ANDA205977
ndc (product): 31722-876

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITAVASTATIN CALCIUM2.09 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
e9622824-cee5-49d7-9273-f18b9cc176fdAvailable 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
31722-876-90pitavastatin calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-876-90EA - Each31722-8769f3a83ab-adb4-4ace-b568-8a7897a10bf612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-876PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240507_e9622824-cee5-49d7-9273-f18b9cc176fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861643pitavastatin calcium 1 MG Oral TabletPSNe9622824-cee5-49d7-9273-f18b9cc176fd1
861648pitavastatin calcium 2 MG Oral TabletPSNe9622824-cee5-49d7-9273-f18b9cc176fd1
861652pitavastatin calcium 4 MG Oral TabletPSNe9622824-cee5-49d7-9273-f18b9cc176fd1
861643pitavastatin calcium 1 MG Oral TabletSCDe9622824-cee5-49d7-9273-f18b9cc176fd1
861648pitavastatin calcium 2 MG Oral TabletSCDe9622824-cee5-49d7-9273-f18b9cc176fd1
861652pitavastatin calcium 4 MG Oral TabletSCDe9622824-cee5-49d7-9273-f18b9cc176fd1
861643pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral TabletSYe9622824-cee5-49d7-9273-f18b9cc176fd1
861648pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral TabletSYe9622824-cee5-49d7-9273-f18b9cc176fd1
861652pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral TabletSYe9622824-cee5-49d7-9273-f18b9cc176fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-876-903172208769090 TABLET, FILM COATED in 1 BOTTLE (31722-876-90) 2024-04-30NoNoCurrent