Home NDC 0378-5057 Pitavastatin Calcium
Product NDC 0378-5057
11-digit product format 003785057
Labeler code 0378
Product ID 0378-5057_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 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 43 .
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 RLD / RS Approval date A206070-001 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 A206070-002 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 A206070-003 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206070-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2019-04-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206070-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2019-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206070-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2019-04-04 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pitavastatin Calcium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITAVASTATIN CALCIUM 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IYD54XEG3W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861643 Internal RxNorm lookup 861648 Internal RxNorm lookup 861652 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-5057-77 Pitavastatin Calcium 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5057 PITAVASTATIN CALCIUM (PITAVASTATIN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 Current NDC, 1 package rows 20240828_26b5e5e8-45cd-4a98-9af4-2d04c1130881.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0378-5057-77 00378505777 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5057-77) 2023-11-02 No No Current