NDC 69344-111

Arymo ER

Morphine Sulfate

Arymo ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Egalet Us Inc.. The primary component is Morphine Sulfate.

• Product ID: 69344-111_a9e64fc1-683a-483e-8754-b759844174bb
• NDC: 69344-111
• Product Type: Human Prescription Drug
• Proprietary Name: Arymo ER
• Generic Name: Morphine Sulfate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA208603
• Labeler Name: Egalet US Inc.
• Substance Name: MORPHINE SULFATE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69344-111-11

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69344-111-11)

• Marketing Start Date: 2017-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69344-111-11 [69344011111]

Arymo ER TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208603
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-01

Drug Details

Active Ingredients

Ingredient	Strength
MORPHINE SULFATE	15 mg/1

OpenFDA Data

• SPL SET ID: e60552c9-06ce-4790-95e7-aadd4df12b2a
• Manufacturer:
  • Egalet US Inc.
• UNII:
  • X3P646A2J0
• RxNorm Concept Unique ID - RxCUI:
  • 1871446
  • 1871444
  • 1871443
  • 1871440
  • 1871441
  • 1871434
• UPC Code:
  • 0369344311112
  • 0369344111118
  • 0369344211115

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Arymo ER" or generic name "Morphine Sulfate"

NDC	Brand Name	Generic Name
69344-211	Arymo ER	Arymo ER
69344-111	Arymo ER	Arymo ER
69344-311	Arymo ER	Arymo ER
0023-6011	Kadian	morphine sulfate
0023-6012	Kadian	morphine sulfate
0023-6013	Kadian	morphine sulfate
0023-6014	Kadian	morphine sulfate
0023-6015	Kadian	morphine sulfate
0023-6016	Kadian	morphine sulfate
0023-6017	Kadian	morphine sulfate
0023-6018	Kadian	morphine sulfate
0023-6019	Kadian	morphine sulfate