NDC 35356-838

Morphine Sulfate Extended Release

Morphine Sulfate

Morphine Sulfate Extended Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Morphine Sulfate.

Product ID35356-838_b1f8e957-af89-427a-bfb1-3b7f49cdb800
NDC35356-838
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate Extended Release
Generic NameMorphine Sulfate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA074862
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameMORPHINE SULFATE
Active Ingredient Strength30 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-838-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-838-30)
Marketing Start Date2011-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-838-30 [35356083830]

Morphine Sulfate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-14

NDC 35356-838-90 [35356083890]

Morphine Sulfate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-14

NDC 35356-838-60 [35356083860]

Morphine Sulfate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA074862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-14
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE30 mg/1

OpenFDA Data

SPL SET ID:36defcbb-bbf8-4e2d-a310-d8095626fec3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891888
  • 891881
  • 891893
  • 892646

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Morphine Sulfate Extended Release" or generic name "Morphine Sulfate"

    NDCBrand NameGeneric Name
    68084-157Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    68084-158Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    0904-6557Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    0904-6558Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    0904-6559Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    0904-6560Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    35356-833morphine sulfate extended releasemorphine sulfate extended release
    35356-836morphine sulfate extended releasemorphine sulfate extended release
    35356-838Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    42858-801Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    42858-802Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    42858-805Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    42858-804Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    42858-803Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    63629-3979Morphine Sulfate Extended ReleaseMorphine Sulfate Extended Release
    63629-4515morphine sulfate extended releasemorphine sulfate extended release
    63629-4514morphine sulfate extended releasemorphine sulfate extended release
    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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