NDC 58177-310

Morphine Sulfate

Morphine Sulfate

Morphine Sulfate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ethex Corporation. The primary component is Morphine Sulfate.

• Product ID: 58177-310_44b9cb00-c457-4cc3-99e3-0db1be101fcd
• NDC: 58177-310
• Product Type: Human Prescription Drug
• Proprietary Name: Morphine Sulfate
• Generic Name: Morphine Sulfate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-12-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076733
• Labeler Name: ETHEX Corporation
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58177-310-04

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-310-04)

• Marketing Start Date: 2009-12-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58177-310-04 [58177031004]

Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076733
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-12-03
• Inactivation Date: 2019-10-21

NDC 58177-310-11 [58177031011]

Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076733
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-12-03
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
MORPHINE SULFATE	15 mg/1

OpenFDA Data

• SPL SET ID: 1a2c9474-fab6-41a0-844d-d6bd5e6a4341
• Manufacturer:
  • ETHEX Corporation
• UNII:
  • X3P646A2J0
• RxNorm Concept Unique ID - RxCUI:
  • 891888
  • 891881
  • 891893
  • 891874
  • 892646
• UPC Code:
  • 0358177380044
  • 0358177310041
  • 0358177340048

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0409-3814	Morphine Sulfate	Morphine Sulfate
0409-3815	Morphine Sulfate	Morphine Sulfate
0409-6028	Morphine Sulfate	Morphine Sulfate
68084-403	Morphine Sulfate	Morphine Sulfate
68084-404	Morphine Sulfate	Morphine Sulfate
68094-754	Morphine Sulfate	Morphine Sulfate
68094-001	Morphine Sulfate	Morphine Sulfate
68094-755	Morphine Sulfate	Morphine Sulfate
0054-0404	Morphine Sulfate	Morphine Sulfate
0054-0517	Morphine Sulfate	Morphine Sulfate
68382-906	MORPHINE SULFATE	MORPHINE SULFATE
68382-903	MORPHINE SULFATE	MORPHINE SULFATE
68382-904	MORPHINE SULFATE	MORPHINE SULFATE
68382-907	MORPHINE SULFATE	MORPHINE SULFATE
68382-905	MORPHINE SULFATE	MORPHINE SULFATE
0527-1425	Morphine Sulfate	Morphine Sulfate
0527-1906	Morphine Sulfate	Morphine Sulfate
0574-7110	Morphine Sulfate	Morphine Sulfate
0574-0153	morphine sulfate	morphine sulfate
0574-7116	Morphine Sulfate	Morphine Sulfate
70166-101	Morphine Sulfate	Morphine Sulfate
0574-7114	Morphine Sulfate	Morphine Sulfate
0574-7112	Morphine Sulfate	Morphine Sulfate
70408-359	Morphine Sulfate	Morphine Sulfate
70518-1107	Morphine Sulfate	Morphine Sulfate
71335-0605	Morphine sulfate	Morphine sulfate
71335-0676	Morphine sulfate	Morphine sulfate
71335-0239	Morphine sulfate	Morphine sulfate
71335-0707	Morphine sulfate	Morphine sulfate
71335-0628	Morphine sulfate	Morphine sulfate
71335-0736	Morphine sulfate	Morphine sulfate
76045-007	Morphine Sulfate	Morphine Sulfate
76045-008	Morphine Sulfate	Morphine Sulfate
76045-004	Morphine Sulfate	Morphine Sulfate
76045-005	Morphine Sulfate	Morphine Sulfate
76045-006	Morphine Sulfate	Morphine Sulfate
76329-1911	Morphine Sulfate	Morphine Sulfate
0641-6126	Morphine Sulfate	Morphine Sulfate
0641-6127	Morphine Sulfate	Morphine Sulfate
0641-6125	Morphine Sulfate	Morphine Sulfate
0832-0228	Morphine Sulfate	Morphine Sulfate
0832-0230	Morphine Sulfate	Morphine Sulfate
0832-0227	Morphine Sulfate	Morphine Sulfate
0832-0233	Morphine Sulfate	Morphine Sulfate
0832-0226	Morphine Sulfate	Morphine Sulfate
0832-0229	Morphine Sulfate	Morphine Sulfate
0832-0225	Morphine Sulfate	Morphine Sulfate
11704-235	Morphine Sulfate	Morphine Sulfate
17856-0403	Morphine Sulfate	Morphine Sulfate
17856-0237	Morphine Sulfate	Morphine Sulfate