NDC 0904-6559

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 Major Pharmaceuticals. The primary component is Morphine Sulfate.

Product ID0904-6559_1d09145e-68dc-483a-a967-5481bc5a8dec
NDC0904-6559
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 NameMajor Pharmaceuticals
Substance NameMORPHINE SULFATE
Active Ingredient Strength60 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0904-6559-61

100 BLISTER PACK in 1 CARTON (0904-6559-61) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2011-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6559-61 [00904655961]

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

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE60 mg/1

OpenFDA Data

SPL SET ID:dbb37dfd-0196-45f7-b9ca-393f56cf1d28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 891888
  • 891881
  • 891893
  • 891874

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