NDC 0641-6039

INFUMORPH 200

Morphine Sulfate

INFUMORPH 200 is a Epidural; Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Morphine Sulfate.

Product ID0641-6039_4966618f-533a-43b0-bf9e-9b3b3a256120
NDC0641-6039
Product TypeHuman Prescription Drug
Proprietary NameINFUMORPH 200
Generic NameMorphine Sulfate
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INTRATHECAL
Marketing Start Date1984-09-18
Marketing CategoryNDA / NDA
Application NumberNDA018565
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameMORPHINE SULFATE
Active Ingredient Strength10 mg/mL
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0641-6039-01

20 mL in 1 AMPULE (0641-6039-01)
Marketing Start Date1984-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6039-01 [00641603901]

INFUMORPH 200 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018565
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-09-18

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE10 mg/mL

OpenFDA Data

SPL SET ID:db9ac9e3-d761-4a99-9f34-4946ebe8f255
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892652
  • 1731999
  • 1731998
  • 1731522
  • Pharmacological Class

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

    NDC Crossover Matching brand name "INFUMORPH 200" or generic name "Morphine Sulfate"

    NDCBrand NameGeneric Name
    0641-6039INFUMORPH 200INFUMORPH 200
    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

    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.