NDC 76045-007

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 ID76045-007_0974f717-3ae3-479a-8389-d4c01b207532
NDC76045-007
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate
Generic NameMorphine Sulfate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2013-10-30
Marketing CategoryNDA / NDA
Application NumberNDA204223
Labeler NameFresenius Kabi USA, LLC
Substance NameMORPHINE SULFATE
Active Ingredient Strength8 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76045-007-10

24 BLISTER PACK in 1 CARTON (76045-007-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-007-00) > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2013-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76045-007-00 [76045000700]

Morphine Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23
Marketing End Date2019-10-23

NDC 76045-007-11 [76045000711]

Morphine Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-25

NDC 76045-007-10 [76045000710]

Morphine Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-30
Marketing End Date2018-11-30

NDC 76045-007-01 [76045000701]

Morphine Sulfate INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA204223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-30

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE8 mg/mL

OpenFDA Data

SPL SET ID:b62ee1ef-db55-417a-a02e-b103890f9c4b
Manufacturer
UNII
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"

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