Home NDC 84230-551-07 Mulpleta
Product NDC 84230-551
Requested package NDC 84230-551-07
11-digit product format 842300551
Labeler code 84230
Product ID 84230-551_2a019a0b-29c4-d5ef-e063-6394a90ad52f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lusutrombopag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler VANCOCIN ITALIA SRL
Application NDA210923
Marketing category NDA
Marketing start 2025-12-09
Substance LUSUTROMBOPAG
Active strength 3 mg/1
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210923-001 MULPLETA LUSUTROMBOPAG 3MG TABLET / ORAL RLD, RS 2018-07-31
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 N210923-001 9427402 2031-09-29 Drug product 2018-08-07
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 · 43 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 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210923-001 MULPLETA 3MG TABLET / ORAL RLD, RS 2018-07-31 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210923-001 7601746 2024-09-05 U-2344 Drug substance, Drug product 2018-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210923-001 7601746 2024-09-05 U-2344 Drug substance, Drug product 2018-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210923-001 7601746 2024-09-05 U-2344 Drug substance, Drug product 2018-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210923-001 7601746 2024-09-05 U-2344 Drug substance, Drug product 2018-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210923-001 9427402 2031-09-29 Drug product 2018-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210923-001 7601746 2024-09-05 U-2344 Drug substance, Drug product 2018-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210923-001 8889722 2028-07-29 Drug substance, Drug product 2018-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210923-001 8530668 2030-01-21 Drug substance, Drug product 2018-08-07 d06236e962d9…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mulpleta
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUSUTROMBOPAG 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6LL5JFU42F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2054989 Internal RxNorm lookup 2054995 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 84230-551-07 Mulpleta 1 in 1 CARTON TABLET, FILM COATED 1 6 84230-551-07 Mulpleta 7 in 1 DOSE PACK TABLET, FILM COATED 7 6
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84230-551-07 84230055107 1 DOSE PACK in 1 CARTON (84230-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK 1 dose pack 2025-12-09 No No Current