NDC 0310-1969

MOVANTIK

Naloxegol Oxalate

MOVANTIK is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Naloxegol Oxalate.

• Product ID: 0310-1969_5f112925-e955-4d74-98a3-0d9ae237a73a
• NDC: 0310-1969
• 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: AstraZeneca Pharmaceuticals LP
• Substance Name: NALOXEGOL OXALATE
• Active Ingredient Strength: 13 mg/1
• Pharm Classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-1969-30

30 TABLET, FILM COATED in 1 BOTTLE (0310-1969-30)

• Marketing Start Date: 2015-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-1969-90 [00310196990]

MOVANTIK TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204760
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-06

NDC 0310-1969-95 [00310196995]

MOVANTIK TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204760
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-01

NDC 0310-1969-39 [00310196939]

MOVANTIK TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204760
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-06

NDC 0310-1969-30 [00310196930]

MOVANTIK TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204760
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-06

Drug Details

Active Ingredients

Ingredient	Strength
NALOXEGOL OXALATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: f49c6978-ca7b-4a66-919b-757f8f92ef64
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 65I14TNM33
• RxNorm Concept Unique ID - RxCUI:
  • 1551917
  • 1551923
  • 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