NDC 57664-197

Morphine Sulfate Extended-Release

Morphine Sulfate Extended-release

Morphine Sulfate Extended-Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Morphine Sulfate.

• Product ID: 57664-197_916c8c9c-c86a-4e82-9a89-cf0c7fdeb385
• NDC: 57664-197
• Product Type: Human Prescription Drug
• Proprietary Name: Morphine Sulfate Extended-Release
• Generic Name: Morphine Sulfate Extended-release
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205634
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: MORPHINE SULFATE
• Active Ingredient Strength: 200 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 57664-197-88

100 TABLET in 1 BOTTLE, PLASTIC (57664-197-88)

• Marketing Start Date: 2016-09-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57664-197-88 [57664019788]

Morphine Sulfate Extended-Release TABLET

• Marketing Category: ANDA
• Application Number: ANDA205634
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-13

Drug Details

Active Ingredients

Ingredient	Strength
MORPHINE SULFATE	200 mg/1

OpenFDA Data

• SPL SET ID: 6208902e-4e2f-4b91-8a24-29f122aa7b24
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • X3P646A2J0
• RxNorm Concept Unique ID - RxCUI:
  • 891878
  • 891883
  • 891885
  • 894918
  • 891890
• UPC Code:
  • 0357664197882
  • 0357664192887
  • 0357664190883
  • 0357664191880
  • 0357664196885

Pharmacological Class

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

NDC Crossover Matching brand name "Morphine Sulfate Extended-Release" or generic name "Morphine Sulfate Extended-release"

NDC	Brand Name	Generic Name
57664-190	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release
57664-191	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release
57664-192	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release
57664-196	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release
57664-197	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release