Mulpleta

Product NDC
85320-551
11-digit product format
853200551
Labeler code
85320
Product ID
85320-551_450774dd-f9dc-b934-e063-6294a90a9a6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lusutrombopag
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eddingpharm (U. S. ) Inc.
Application
NDA210923
Marketing category
NDA
Marketing start
2025-11-24
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210923-001MULPLETALUSUTROMBOPAG3MGTABLET / ORALRLD, RS2018-07-31

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210923-00188897222028-07-29Drug substance, Drug product2018-08-07
N210923-00185306682030-01-21Drug substance, Drug product2018-08-07
N210923-00194274022031-09-29Drug product2018-08-07

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210923-001MULPLETA3MGTABLET / ORALRLD, RS2018-07-31cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 158 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210923-00188897222028-07-29Drug substance, Drug product2018-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210923-00185306682030-01-21Drug substance, Drug product2018-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210923-00194274022031-09-29Drug product2018-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210923-00188897222028-07-29Drug substance, Drug product2018-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210923-00185306682030-01-21Drug substance, Drug product2018-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210923-00194274022031-09-29Drug product2018-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210923-00188897222028-07-29Drug substance, Drug product2018-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210923-00185306682030-01-21Drug substance, Drug product2018-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210923-00194274022031-09-29Drug product2018-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210923-00188897222028-07-29Drug substance, Drug product2018-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210923-00185306682030-01-21Drug substance, Drug product2018-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210923-00194274022031-09-29Drug product2018-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210923-00188897222028-07-29Drug substance, Drug product2018-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210923-00185306682030-01-21Drug substance, Drug product2018-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210923-00194274022031-09-29Drug product2018-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210923-00188897222028-07-29Drug substance, Drug product2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210923-00185306682030-01-21Drug substance, Drug product2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210923-00194274022031-09-29Drug product2018-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210923-00188897222028-07-29Drug substance, Drug product2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210923-00185306682030-01-21Drug substance, Drug product2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210923-00194274022031-09-29Drug product2018-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210923-00188897222028-07-29Drug substance, Drug product2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210923-00185306682030-01-21Drug substance, Drug product2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210923-00194274022031-09-29Drug product2018-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210923-00188897222028-07-29Drug substance, Drug product2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210923-00185306682030-01-21Drug substance, Drug product2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210923-00194274022031-09-29Drug product2018-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N210923-00188897222028-07-29Drug substance, Drug product2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N210923-00185306682030-01-21Drug substance, Drug product2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N210923-00194274022031-09-29Drug product2018-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210923-00188897222028-07-29Drug substance, Drug product2018-08-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210923-00185306682030-01-21Drug substance, Drug product2018-08-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210923-00194274022031-09-29Drug product2018-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210923-00176017462024-09-05U-2344Drug substance, Drug product2018-08-07301d65b070ca…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210923-001NCE2023-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210923-001NCE2023-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210923-001NCE2023-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210923-001NCE2023-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210923-001NCE2023-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210923-001NCE2023-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210923-001NCE2023-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N210923-001NCE2023-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210923-001NCE2023-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210923-001NCE2023-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210923-001NCE2023-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09N210923-001NCE2023-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N210923-001NCE2023-07-31ea99ee380514…
2023-12-20 04:57 UTC2023-12N210923-001NCE2023-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210923-001NCE2023-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210923-001NCE2023-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210923-001NCE2023-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210923-001NCE2023-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N210923-001NCE2023-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N210923-001NCE2023-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210923-001NCE2023-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210923-001NCE2023-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210923-001NCE2023-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210923-001NCE2023-07-31cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUSUTROMBOPAG3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6LL5JFU42FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2054989Internal RxNorm lookup
2054995Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f6b72db-3abc-4169-9bee-8dc3078357e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
bf82b36f-3fb0-49c2-b359-79c91ec8a6e9Product name120181011
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85320-551-07Mulpleta1 in 1 CARTONTABLET, FILM COATED13
85320-551-07Mulpleta7 in 1 DOSE PACKTABLET, FILM COATED73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85320-551-07EA - Each85320-551a7343d64-245c-4252-8880-61edc290e47c12025-12-16

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MulpletaLUSUTROMBOPAGVANCOCIN ITALIA SRLa390aec3-6e77-45f8-95d3-d4b8c2eeee402025-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 210923
application number: NDA210923
MulpletaLUSUTROMBOPAGEddingpharm (U. S. ) Inc.3f6b72db-3abc-4169-9bee-8dc3078357e62025-11-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 210923
application number: NDA210923
ndc (product): 85320-551
MulpletaLUSUTROMBOPAGSHIONOGI INC.f9fd0cfd-717d-4a87-99bc-de7b38807e552020-10-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 210923
application number: NDA210923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054989lusutrombopag 3 MG Oral TabletPSN3f6b72db-3abc-4169-9bee-8dc3078357e63
2054995MULPLETA 3 MG Oral TabletPSN3f6b72db-3abc-4169-9bee-8dc3078357e63
2054995lusutrombopag 3 MG Oral Tablet [Mulpleta]SBD3f6b72db-3abc-4169-9bee-8dc3078357e63
2054989lusutrombopag 3 MG Oral TabletSCD3f6b72db-3abc-4169-9bee-8dc3078357e63
2054995Mulpleta 3 MG Oral TabletSY3f6b72db-3abc-4169-9bee-8dc3078357e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85320-551-07853200551071 DOSE PACK in 1 CARTON (85320-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK1 dose pack2025-11-24NoNoCurrent