NDC 70408-746

Morphine Sulfate Oral Solution CII

Morphine Sulfate

Morphine Sulfate Oral Solution CII is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Nostrum Laboratories, Inc.. The primary component is Morphine Sulfate.

Product ID70408-746_bad0ef41-e4f5-4a4b-af96-9de08f83a612
NDC70408-746
Product TypeHuman Prescription Drug
Proprietary NameMorphine Sulfate Oral Solution CII
Generic NameMorphine Sulfate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-10-06
Marketing CategoryANDA / ANDA
Application NumberANDA201011
Labeler NameNostrum Laboratories, Inc.
Substance NameMORPHINE SULFATE
Active Ingredient Strength100 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70408-746-29

30 mL in 1 BOTTLE (70408-746-29)
Marketing Start Date2016-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70408-746-29 [70408074629]

Morphine Sulfate Oral Solution CII SOLUTION
Marketing CategoryANDA
Application NumberANDA201011
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-06

NDC 70408-746-31 [70408074631]

Morphine Sulfate Oral Solution CII SOLUTION
Marketing CategoryANDA
Application NumberANDA201011
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-06

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE100 mg/5mL

OpenFDA Data

SPL SET ID:d6ec8aec-1abd-4fcc-a780-e77a4cf93e39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892625
  • UPC Code
  • 0370408746313
  • 0370408746290
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Morphine Sulfate Oral Solution CII" or generic name "Morphine Sulfate"

    NDCBrand NameGeneric Name
    70408-746Morphine Sulfate Oral Solution CIIMorphine Sulfate Oral Solution CII
    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.