NDC 55700-383

MOVANTIK

Naloxegol Oxalate

MOVANTIK is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Naloxegol Oxalate.

• Product ID: 55700-383_df64082c-a5c5-4d74-adc5-065cf9b0b061
• NDC: 55700-383
• Product Type: Human Prescription Drug
• Proprietary Name: MOVANTIK
• Generic Name: Naloxegol Oxalate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-06
• Marketing Category: NDA / NDA
• Application Number: NDA204760
• Labeler Name: Quality Care Products, LLC
• Substance Name: NALOXEGOL OXALATE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 55700-383-30

30 TABLET, FILM COATED in 1 BOTTLE (55700-383-30)

• Marketing Start Date: 2016-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55700-383-30 [55700038330]

MOVANTIK TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204760
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-26

Drug Details

Active Ingredients

Ingredient	Strength
NALOXEGOL OXALATE	25 mg/1

OpenFDA Data

• SPL SET ID: 5c02665d-05d2-4e99-b403-c270de543ebe
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• UNII:
  • 65I14TNM33
• RxNorm Concept Unique ID - RxCUI:
  • 1601373
  • 1551782

Pharmacological Class

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

NDC Crossover Matching brand name "MOVANTIK" or generic name "Naloxegol Oxalate"

NDC	Brand Name	Generic Name
0310-1969	MOVANTIK	naloxegol oxalate
0310-1970	MOVANTIK	naloxegol oxalate
55700-383	MOVANTIK	naloxegol oxalate
55700-988	MOVANTIK	naloxegol oxalate
57841-1300	MOVANTIK	naloxegol oxalate
57841-1301	MOVANTIK	naloxegol oxalate