NDC 35356-833

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 ID35356-833_b1f8e957-af89-427a-bfb1-3b7f49cdb800
NDC35356-833
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 Strength60 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-833-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-833-60)
Marketing Start Date2011-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-833-60 [35356083360]

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 35356-833-30 [35356083330]

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 35356-833-01 [35356083301]

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 Date2017-06-01

NDC 35356-833-90 [35356083390]

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 Date2016-12-31

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE60 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]