NDC 63629-4483

Morphine Sulfate ER

Morphine Sulfate

Morphine Sulfate ER 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 ID63629-4483_872ceecb-1f14-7a43-7451-e4650a01fbd9
NDC63629-4483
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate ER
Generic NameMorphine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA074862
Labeler NameBryant Ranch Prepack
Substance NameMORPHINE SULFATE
Active Ingredient Strength15 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-4483-0

26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0)
Marketing Start Date2022-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4483-0 [63629448300]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-5 [63629448305]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-8 [63629448308]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-3 [63629448303]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-6 [63629448306]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-2 [63629448302]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-9 [63629448309]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-7 [63629448307]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-1 [63629448301]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

NDC 63629-4483-4 [63629448304]

Morphine Sulfate ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE15 mg/1

OpenFDA Data

SPL SET ID:872ceecb-1f14-7a43-7451-e4650a01fbd9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891881

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Morphine Sulfate ER" or generic name "Morphine Sulfate"

    NDCBrand NameGeneric Name
    63629-4483Morphine Sulfate ERMorphine Sulfate ER
    0023-6011Kadianmorphine sulfate
    0023-6012Kadianmorphine sulfate
    0023-6013Kadianmorphine sulfate
    0023-6014Kadianmorphine sulfate
    0023-6015Kadianmorphine sulfate
    0023-6016Kadianmorphine sulfate
    0023-6017Kadianmorphine sulfate
    0023-6018Kadianmorphine sulfate
    0023-6019Kadianmorphine sulfate
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