pitavastatin calcium

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:51

Label at a glance#

Productpitavastatin calcium

Active ingredientPITAVASTATIN CALCIUM

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pitavastatin Tablets, 1 mg

NDC 70771-1784-9

Bottle of 90 tablets

Rx only

Pitavastatin Tablets, 2 mg

NDC 70771-1785-9

Bottle of 90 tablets

Rx only

Pitavastatin Tablets, 4 mg

NDC 70771-1786-9

Bottle of 90 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
861643	pitavastatin calcium 1 MG Oral Tablet	PSN	5
861648	pitavastatin calcium 2 MG Oral Tablet	PSN	5
861652	pitavastatin calcium 4 MG Oral Tablet	PSN	5
861643	pitavastatin calcium 1 MG Oral Tablet	SCD	5
861648	pitavastatin calcium 2 MG Oral Tablet	SCD	5
861652	pitavastatin calcium 4 MG Oral Tablet	SCD	5
861643	pitavastatin 1 MG (as pitavastatin calcium 1.045 MG) Oral Tablet	SY	5
861648	pitavastatin 2 MG (as pitavastatin calcium 2.09 MG) Oral Tablet	SY	5
861652	pitavastatin 4 MG (as pitavastatin calcium 4.18 MG) Oral Tablet	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PITAVASTATIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3b6a39e-87bf-f126-1bde-83d69cbf558b	Product name	3	20250219
de94155c-7345-40be-9a5b-89d04e1ac565	Product name	1	20190313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1784-9	pitavastatin calcium	90 in 1 BOTTLE	TABLET	90	5
70771-1785-9	pitavastatin calcium	90 in 1 BOTTLE	TABLET	90	5
70771-1786-9	pitavastatin calcium	90 in 1 BOTTLE	TABLET	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1784	PITAVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, 1 package rows	20241207_7b1a9aa6-a7a4-4050-8a40-89ba9728555a.zip
70771-1785	PITAVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, 1 package rows	20241207_7b1a9aa6-a7a4-4050-8a40-89ba9728555a.zip
70771-1786	PITAVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, 1 package rows	20241207_7b1a9aa6-a7a4-4050-8a40-89ba9728555a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

pitavastatin calcium
PITAVASTATIN
CALCIUM CARBONATE
CROSPOVIDONE (120 .MU.M)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM CARBONATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1784	70771-1784-9
70771-1785	70771-1785-9
70771-1786	70771-1786-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PITAVASTATIN CALCIUM	IYD54XEG3W	ACTIM
CALCIUM CARBONATE	H0G9379FGK	IACT
CROSPOVIDONE (120 .MU.M)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM CARBONATE	45P3261C7T	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PITAVASTATIN CALCIUM	IYD54XEG3W	ACTIM
CALCIUM CARBONATE	H0G9379FGK	IACT
CROSPOVIDONE (120 .MU.M)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM CARBONATE	45P3261C7T	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PITAVASTATIN CALCIUM	IYD54XEG3W	ACTIM
CALCIUM CARBONATE	H0G9379FGK	IACT
CROSPOVIDONE (120 .MU.M)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM CARBONATE	45P3261C7T	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206047-001	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22
A206047-002	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22
A206047-003	PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22

Therapeutic equivalence codes#

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

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

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.

Product history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206047-002	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	2023-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206047-003	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	2023-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206047-001	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	2023-02-22	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206047-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206047-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206047-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206047-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206047-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206047-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206047-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206047-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206047-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206047-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206047-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206047-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206047-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206047-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206047-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206047-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206047-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206047-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206047-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206047-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206047-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206047-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206047-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206047-001	AB	1	`79d66fd596c7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pitavastatin calcium	PITAVASTATIN CALCIUM	Zydus Lifesciences Limited	7b1a9aa6-a7a4-4050-8a40-89ba9728555a	2024-12-03		Exact identifier ndc (package): 70771-1784-9 ndc (package): 70771-1785-9 ndc (package): 70771-1786-9 ndc (product): 70771-1786 ndc (product): 70771-1784 ndc (product): 70771-1785 ndc11 (package): 70771178509 ndc11 (package): 70771178409 ndc11 (package): 70771178609 spl id: e441676b-f28d-4506-9b0e-b8e28b1f7d1f spl set id: 7b1a9aa6-a7a4-4050-8a40-89ba9728555a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.