NDC 40032-544

Morphine Sulfate

Morphine Sulfate

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

Product ID40032-544_4073de0a-5149-4619-a254-67715296b8fc
NDC40032-544
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate
Generic NameMorphine Sulfate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA203602
Labeler NameNovel Laboratories, Inc.
Substance NameMORPHINE SULFATE
Active Ingredient Strength200 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 40032-544-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-544-01)
Marketing Start Date2015-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40032-544-01 [40032054401]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-16

NDC 40032-544-03 [40032054403]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-16
Marketing End Date2019-12-21

NDC 40032-544-05 [40032054405]

Morphine Sulfate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-16

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE200 mg/1

OpenFDA Data

SPL SET ID:e044604d-f210-4411-a6e8-6a9dbdb1a9bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891888
  • 891881
  • 891893
  • 891874
  • 892646
  • 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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