NDC 66794-160

MITIGO

Morphine Sulfate

MITIGO is a Epidural; Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Piramal Critical Care, Inc.. The primary component is Morphine Sulfate.

Product ID66794-160_728f3d83-9a64-0c1f-e053-2a91aa0ac7db
NDC66794-160
Product TypeHuman Prescription Drug
Proprietary NameMITIGO
Generic NameMorphine Sulfate
Dosage FormInjection
Route of AdministrationEPIDURAL; INTRATHECAL
Marketing Start Date2018-09-03
Marketing CategoryANDA / ANDA
Application NumberANDA204393
Labeler NamePiramal Critical Care, Inc.
Substance NameMORPHINE SULFATE
Active Ingredient Strength200 mg/20mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66794-160-02

1 mL in 1 VIAL, SINGLE-USE (66794-160-02)
Marketing Start Date2019-02-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66794-160-02 [66794016002]

MITIGO INJECTION
Marketing CategoryANDA
Application NumberANDA204393
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-25

Drug Details

Active Ingredients

IngredientStrength
MORPHINE SULFATE200 mg/20mL

OpenFDA Data

SPL SET ID:728f3d83-9a63-0c1f-e053-2a91aa0ac7db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2055307
  • 1731998
  • 1731522
  • 2055311
    • UPC Code
  • 0366794162028
  • 0366794160024

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    66794-162MITIGOMITIGO
    66794-160MITIGOMITIGO
    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 [MITIGO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MITIGO
    MITIGO
    88130886 not registered Live/Pending
    Piramal Critical Care Limited
    2018-09-25
    MITIGO
    MITIGO
    88130841 not registered Live/Pending
    Piramal Critical Care Limited
    2018-09-25
    MITIGO
    MITIGO
    85916348 not registered Dead/Abandoned
    Mallinckrodt LLC
    2013-04-26
    MITIGO
    MITIGO
    76537401 2986829 Dead/Cancelled
    KAMEDIS LTD.
    2003-08-14
    MITIGO
    MITIGO
    76261626 not registered Dead/Abandoned
    Boler Company, The
    2001-05-23
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.