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 ID: 59385-041_25f2969e-51fe-4cea-80ba-6be461a7b92f
• NDC: 59385-041
• Product Type: Human Prescription Drug
• Proprietary Name: SYMPROIC
• Generic Name: Naldemedine Tosylate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-14
• Marketing Category: NDA / NDA
• Application Number: NDA208854
• Labeler Name: BioDelivery Sciences International Inc
• Substance Name: NALDEMEDINE TOSYLATE
• Active Ingredient Strength: 0 mg/1
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59385-041-07

1 BLISTER PACK in 1 CARTON (59385-041-07) > 7 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2020-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59385-041-30 [59385004130]

SYMPROIC TABLET

• Marketing Category: NDA
• Application Number: NDA208854
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-14

NDC 59385-041-09 [59385004109]

SYMPROIC TABLET

• Marketing Category: NDA
• Application Number: NDA208854
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-01
• Marketing End Date: 2019-12-03

Drug Details

Active Ingredients

Ingredient	Strength
NALDEMEDINE TOSYLATE	.2 mg/1

OpenFDA Data

• SPL SET ID: b1a1256c-a1eb-4abe-ab1e-30e4711afd16
• Manufacturer:
  • BioDelivery Sciences International Inc
• UNII:
  • V1N8F1RVVO

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59011-523	Symproic	naldemedine
59385-041	SYMPROIC	naldemedine tosylate
59630-222	SYMPROIC	naldemedine