NDC 71335-0628

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 Bryant Ranch Prepack. The primary component is Morphine Sulfate.

Product ID71335-0628_e2f0c433-c524-4921-a087-7b86e60df69b
NDC71335-0628
Product TypeHuman Prescription Drug
Proprietary NameMorphine sulfate
Generic NameMorphine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA203849
Labeler NameBryant Ranch Prepack
Substance NameMORPHINE SULFATE
Active Ingredient Strength60 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0628-1

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0628-1)
Marketing Start Date2016-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0628-7 [71335062807]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-2 [71335062802]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-5 [71335062805]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-4 [71335062804]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-8 [71335062808]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-1 [71335062801]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-6 [71335062806]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

NDC 71335-0628-3 [71335062803]

Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-06

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE60 mg/1

OpenFDA Data

SPL SET ID:a48a89b3-766b-4a81-a176-89250188a1e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891888
  • 891881
  • 891893
  • 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.