NDC 0115-1279

Morphine Sulfate

Morphine Sulfate

Morphine Sulfate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Morphine Sulfate.

Product ID0115-1279_0dd1f46e-85a0-4b90-952d-da87dbdb5e61
NDC0115-1279
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate
Generic NameMorphine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA200411
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameMORPHINE SULFATE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0115-1279-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-01)
Marketing Start Date2016-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1279-03 [00115127903]

Morphine Sulfate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200411
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-12

NDC 0115-1279-08 [00115127908]

Morphine Sulfate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200411
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-12

NDC 0115-1279-01 [00115127901]

Morphine Sulfate CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200411
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-12

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE50 mg/1

OpenFDA Data

SPL SET ID:f7e9a4b3-a2ee-4f0a-becd-6ef90867332b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892596
  • 1303736
  • 894814
  • 894801
  • 892554
  • 892352
  • 892345
  • UPC Code
  • 0301151282018
  • 0301151277014
  • 0301151281011
  • 0301151278011
  • 0301151479012
  • 0301151279018
  • 0301151280014
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.