NDC 58177-380

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 ID58177-380_44b9cb00-c457-4cc3-99e3-0db1be101fcd
NDC58177-380
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate
Generic NameMorphine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077855
Labeler NameETHEX Corporation
Substance NameMORPHINE SULFATE
Active Ingredient Strength200 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58177-380-04

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-380-04)
Marketing Start Date2009-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58177-380-04 [58177038004]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-01
Inactivation Date2019-10-21

NDC 58177-380-09 [58177038009]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-01
Inactivation Date2019-10-21

NDC 58177-380-11 [58177038011]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA077855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-01-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE200 mg/1

OpenFDA Data

SPL SET ID:1a2c9474-fab6-41a0-844d-d6bd5e6a4341
Manufacturer
UNII
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"

    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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