NDC 0641-6019

Duramorph

Morphine Sulfate

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

Product ID0641-6019_613bbb99-fdf7-4b64-a038-69997e2d944b
NDC0641-6019
Product TypeHuman Prescription Drug
Proprietary NameDuramorph
Generic NameMorphine Sulfate
Dosage FormInjection
Route of AdministrationEPIDURAL; INTRATHECAL; INTRAVENOUS
Marketing Start Date1984-09-18
Marketing CategoryNDA / NDA
Application NumberNDA018565
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameMORPHINE SULFATE
Active Ingredient Strength1 mg/mL
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0641-6019-10

10 AMPULE in 1 CARTON (0641-6019-10) > 10 mL in 1 AMPULE (0641-6019-01)
Marketing Start Date1984-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6019-01 [00641601901]

Duramorph INJECTION
Marketing CategoryNDA
Application NumberNDA018565
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-09-18

NDC 0641-6019-10 [00641601910]

Duramorph INJECTION
Marketing CategoryNDA
Application NumberNDA018565
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-09-18

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE1 mg/mL

OpenFDA Data

SPL SET ID:ebb18761-e5c4-4238-bb84-f9549f500210
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 892489
  • 1728800
  • 892473
  • 1728783

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Duramorph" or generic name "Morphine Sulfate"

    NDCBrand NameGeneric Name
    0641-6019DuramorphDuramorph
    0641-6020DuramorphDuramorph
    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

    Trademark Results [Duramorph]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DURAMORPH
    DURAMORPH
    73272445 1189084 Live/Registered
    A. H. Robins Company, Incorporated
    1980-07-31
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