NDC 76045-004

Morphine Sulfate

Morphine Sulfate

Morphine Sulfate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Morphine Sulfate.

• Product ID: 76045-004_0974f717-3ae3-479a-8389-d4c01b207532
• NDC: 76045-004
• Product Type: Human Prescription Drug
• Proprietary Name: Morphine Sulfate
• Generic Name: Morphine Sulfate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2013-10-30
• Marketing Category: NDA / NDA
• Application Number: NDA204223
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: MORPHINE SULFATE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76045-004-10

24 BLISTER PACK in 1 CARTON (76045-004-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2013-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76045-004-11 [76045000411]

Morphine Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-25

NDC 76045-004-02 [76045000402]

Morphine Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-23
• Marketing End Date: 2019-10-23

NDC 76045-004-10 [76045000410]

Morphine Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-30

NDC 76045-004-01 [76045000401]

Morphine Sulfate INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA204223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-30

Drug Details

Active Ingredients

Ingredient	Strength
MORPHINE SULFATE	2 mg/mL

OpenFDA Data

• SPL SET ID: b62ee1ef-db55-417a-a02e-b103890f9c4b
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • X3P646A2J0
• RxNorm Concept Unique ID - RxCUI:
  • 1442790
  • 894912
  • 894914
  • 998213
  • 998212

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