NDC 59630-222

SYMPROIC

Naldemedine

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

• Product ID: 59630-222_41985d7d-0aa5-4ca5-a730-997330c1108e
• NDC: 59630-222
• Product Type: Human Prescription Drug
• Proprietary Name: SYMPROIC
• Generic Name: Naldemedine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-23
• Marketing Category: NDA / NDA
• Application Number: NDA208854
• Labeler Name: Shionogi 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: 2019-12-31

Packaging

NDC 59630-222-30

30 TABLET in 1 BOTTLE (59630-222-30)

• Marketing Start Date: 2018-07-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59630-222-90 [59630022290]

SYMPROIC TABLET

• Marketing Category: NDA
• Application Number: NDA208854
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-05
• Marketing End Date: 2020-12-31

NDC 59630-222-07 [59630022207]

SYMPROIC TABLET

• Marketing Category: NDA
• Application Number: NDA208854
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-05
• Marketing End Date: 2020-12-31

NDC 59630-222-30 [59630022230]

SYMPROIC TABLET

• Marketing Category: NDA
• Application Number: NDA208854
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-05
• Marketing End Date: 2020-12-31

Drug Details

Active Ingredients

Ingredient	Strength
NALDEMEDINE TOSYLATE	.2 mg/1

OpenFDA Data

• SPL SET ID: 12ca7d88-2a0c-4c3b-b61e-f58849c7e9e3
• Manufacturer:
  • Shionogi Inc.
• UNII:
  • V1N8F1RVVO
• RxNorm Concept Unique ID - RxCUI:
  • 1876609
  • 1876603
• UPC Code:
  • 0359630222901

Pharmacological Class

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

Medicade Reported Pricing

59630022290 SYMPROIC 0.2 MG TABLET

Pricing Unit: EA | Drug Type:

59630022230 SYMPROIC 0.2 MG TABLET

Pricing Unit: EA | Drug Type:

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

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