NDC 59385-041

SYMPROIC

Naldemedine Tosylate

SYMPROIC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Biodelivery Sciences International Inc. The primary component is Naldemedine Tosylate.

Product ID59385-041_25f2969e-51fe-4cea-80ba-6be461a7b92f
NDC59385-041
Product TypeHuman Prescription Drug
Proprietary NameSYMPROIC
Generic NameNaldemedine Tosylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-14
Marketing CategoryNDA / NDA
Application NumberNDA208854
Labeler NameBioDelivery Sciences International Inc
Substance NameNALDEMEDINE TOSYLATE
Active Ingredient Strength0 mg/1
Pharm ClassesOpioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59385-041-07

1 BLISTER PACK in 1 CARTON (59385-041-07) > 7 TABLET in 1 BLISTER PACK
Marketing Start Date2020-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59385-041-30 [59385004130]

SYMPROIC TABLET
Marketing CategoryNDA
Application NumberNDA208854
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-14

NDC 59385-041-09 [59385004109]

SYMPROIC TABLET
Marketing CategoryNDA
Application NumberNDA208854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-01
Marketing End Date2019-12-03

Drug Details

Active Ingredients

IngredientStrength
NALDEMEDINE TOSYLATE.2 mg/1

OpenFDA Data

SPL SET ID:b1a1256c-a1eb-4abe-ab1e-30e4711afd16
Manufacturer
UNII

Pharmacological Class

  • Opioid Antagonist [EPC]
  • Opioid Antagonists [MoA]

NDC Crossover Matching brand name "SYMPROIC" or generic name "Naldemedine Tosylate"

NDCBrand NameGeneric Name
59011-523Symproicnaldemedine
59385-041SYMPROICnaldemedine tosylate
59630-222SYMPROICnaldemedine

Trademark Results [SYMPROIC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYMPROIC
SYMPROIC
79168243 4887392 Live/Registered
SHIONOGI & CO., LTD.
2015-01-27

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