Home NDC 66869-204-90 Livalo
Product NDC 66869-204
Requested package NDC 66869-204-90
11-digit product format 668690204
Labeler code 66869
Product ID 66869-204_f558f406-3b8e-4a4b-a817-2fb2e624c79c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pitavastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kowa Pharmaceuticals America, Inc.
Application NDA022363
Marketing category NDA
Marketing start 2019-05-16
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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022363-001 LIVALO PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 N022363-002 LIVALO PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 N022363-003 LIVALO PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03
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 · 123 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 2026-02-19 14:30 UTC 2026-02 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022363-002 LIVALO EQ 2MG BASE TABLET / ORAL AB RLD 2009-08-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022363-003 LIVALO EQ 4MG BASE TABLET / ORAL AB RLD, RS 2009-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022363-001 LIVALO EQ 1MG BASE TABLET / ORAL AB RLD 2009-08-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# Patent history page 1 of 12 · 465 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-001 8557993 2024-02-02 Drug product 2013-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-001 7022713 2024-02-19 U-998 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-001 8557993*PED 2024-08-02 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-001 7022713*PED 2024-08-19 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-002 8557993 2024-02-02 Drug product 2013-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-002 7022713 2024-02-19 U-998 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-002 8557993*PED 2024-08-02 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-002 7022713*PED 2024-08-19 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-003 8557993 2024-02-02 Drug product 2013-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-003 7022713 2024-02-19 U-998 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-003 8557993*PED 2024-08-02 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022363-003 7022713*PED 2024-08-19 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-001 8557993 2024-02-02 Drug product 2013-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-001 7022713 2024-02-19 U-998 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-001 8557993*PED 2024-08-02 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-001 7022713*PED 2024-08-19 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-002 8557993 2024-02-02 Drug product 2013-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-002 7022713 2024-02-19 U-998 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-002 8557993*PED 2024-08-02 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-002 7022713*PED 2024-08-19 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-003 8557993 2024-02-02 Drug product 2013-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-003 7022713 2024-02-19 U-998 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-003 8557993*PED 2024-08-02 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022363-003 7022713*PED 2024-08-19 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-001 8557993 2024-02-02 Drug product 2013-11-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-001 7022713 2024-02-19 U-998 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-001 8557993*PED 2024-08-02 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-001 7022713*PED 2024-08-19 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-002 8557993 2024-02-02 Drug product 2013-11-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-002 7022713 2024-02-19 U-998 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-002 8557993*PED 2024-08-02 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-002 7022713*PED 2024-08-19 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-003 8557993 2024-02-02 Drug product 2013-11-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-003 7022713 2024-02-19 U-998 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-003 8557993*PED 2024-08-02 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022363-003 7022713*PED 2024-08-19 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-001 8557993 2024-02-02 Drug product 2013-11-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-001 7022713 2024-02-19 U-998 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-001 8557993*PED 2024-08-02 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022363-001 7022713*PED 2024-08-19 Pediatric extension d8e5a09893c0…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Livalo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PITAVASTATIN CALCIUM 2.09 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861643 Internal RxNorm lookup 861646 Internal RxNorm lookup 861648 Internal RxNorm lookup 861650 Internal RxNorm lookup 861652 Internal RxNorm lookup 861654 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66869-204-07 Livalo 7 in 1 CARTON TABLET, FILM COATED 7 11 66869-204-90 Livalo 90 in 1 BOTTLE, DISPENSING TABLET, FILM COATED 90 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded pitavastatin calcium ACTIVE INGREDIENT IYD54XEG3W LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 pitavastatin ACTIVE MOIETY M5681Q5F9P LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 hydroxypropyl cellulose, low substituted INACTIVE INGREDIENT 2165RE0K14 LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 magnesium aluminometasilicate type i-b INACTIVE INGREDIENT 8XK1039013 LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66869-204 LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240906_44dcbf97-99ec-427c-ba50-207e0069d6d2.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 Marketing end Sample Exclude flag Status 66869-204-90 66869020490 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90) 2019-05-16 0000-00-00 No No Current