NDC 65597-303

MorphaBond ER

Morphine Sulfate

MorphaBond ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo Inc.. The primary component is Morphine Sulfate.

• Product ID: 65597-303_00e02cb0-f7f2-4f1f-a0a6-c88ce208e14e
• NDC: 65597-303
• Product Type: Human Prescription Drug
• Proprietary Name: MorphaBond ER
• Generic Name: Morphine Sulfate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-02
• Marketing Category: NDA / NDA
• Application Number: NDA206544
• Labeler Name: Daiichi Sankyo Inc.
• Substance Name: MORPHINE SULFATE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65597-303-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65597-303-10)

• Marketing Start Date: 2017-03-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65597-303-10 [65597030310]

MorphaBond ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA206544
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-02

Drug Details

Active Ingredients

Ingredient	Strength
MORPHINE SULFATE	60 mg/1

OpenFDA Data

• SPL SET ID: 1806c935-0a76-4f6a-80c8-4aee8a95cb7d
• Manufacturer:
  • Daiichi Sankyo Inc.
• UNII:
  • X3P646A2J0
• RxNorm Concept Unique ID - RxCUI:
  • 1745889
  • 1745881
  • 1871444
  • 1872234
  • 1745886
  • 1871441
  • 1745892
  • 1871434
• UPC Code:
  • 0365597301108
  • 0365597302105
  • 0365597304109
  • 0365597303102

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
65597-301	MorphaBond ER	MorphaBond ER
65597-302	MorphaBond ER	MorphaBond ER
65597-303	MorphaBond ER	MorphaBond ER
65597-304	MorphaBond ER	MorphaBond 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