FDA.reportPublic FDA data

SYMPROIC

Product NDC
59385-041
11-digit product format
593850041
Labeler code
59385
Product ID
59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naldemedine
Dosage form
TABLET
Route
ORAL
Labeler
BioDelivery Sciences International Inc
Application
NDA208854
Marketing category
NDA
Marketing start
2019-06-14
Substance
NALDEMEDINE TOSYLATE
Active strength
.2 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALDEMEDINE TOSYLATE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1N8F1RVVO
Rxcui1876603, 1876609

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41abf4a1-885f-4fc7-b2a9-9b351a7ae4eaProduct name120170608

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-041-072021-07-30C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-302021-07-30C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-902021-07-30C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-072021-07-23C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-302021-07-23C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017
59385-041-902021-07-23C16284748780-1c7ccaba7-18b4-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC ® (naldemedine tablets for oral use) Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59385-041-07SYMPROIC7 in 1 BLISTER PACKTABLET710
59385-041-07SYMPROIC1 in 1 CARTONTABLET110
59385-041-30SYMPROIC30 in 1 BOTTLE, PLASTICTABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59385-041-30EA - Each59385-041a629b9ab-7e6c-40f7-8c04-7a2784ecd8dc12019-07-02
59385-041-90EA - Each59385-041fdc9aae2-e7c6-4f83-a146-aca2df5a326812019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-041SYMPROIC (NALDEMEDINE) TABLET [BIODELIVERY SCIENCES INTERNATIONAL INC]9Current NDC, Legacy NDC, 3 package rows20221227_b1a1256c-a1eb-4abe-ab1e-30e4711afd16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1876603naldemedine 0.2 MG Oral TabletPSNb1a1256c-a1eb-4abe-ab1e-30e4711afd1610
1876609Symproic 0.2 MG Oral TabletPSNb1a1256c-a1eb-4abe-ab1e-30e4711afd1610
1876609naldemedine 0.2 MG Oral Tablet [Symproic]SBDb1a1256c-a1eb-4abe-ab1e-30e4711afd1610
1876603naldemedine 0.2 MG Oral TabletSCDb1a1256c-a1eb-4abe-ab1e-30e4711afd1610
1876603naldemedine (as naldemedine tosylate) 0.2 MG Oral TabletSYb1a1256c-a1eb-4abe-ab1e-30e4711afd1610
1876609Symproic 0.2 MG Oral TabletSYb1a1256c-a1eb-4abe-ab1e-30e4711afd1610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59385-041-07593850041071 BLISTER PACK in 1 CARTON (59385-041-07) > 7 TABLET in 1 BLISTER PACK1 blister pack2020-07-010000-00-00NoNoCurrent
59385-041-305938500413030 TABLET in 1 BOTTLE, PLASTIC (59385-041-30) 30 tablet2019-06-140000-00-00NoNoCurrent