NDC 59011-442

DILAUDID

Hydromorphone Hydrochloride

DILAUDID is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Purdue Pharma Lp. The primary component is Hydromorphone Hydrochloride.

Product ID59011-442_182d5b8e-6145-60ab-a2ec-a188aa83eb98
NDC59011-442
Product TypeHuman Prescription Drug
Proprietary NameDILAUDID
Generic NameHydromorphone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1926-01-01
Marketing CategoryNDA / NDA
Application NumberNDA019034
Labeler NamePurdue Pharma LP
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59011-442-25

25 AMPULE in 1 CARTON (59011-442-25) > 2 mL in 1 AMPULE
Marketing Start Date1926-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59011-442-10 [59011044210]

DILAUDID INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1926-01-01
Inactivation Date2020-01-31

NDC 59011-442-25 [59011044225]

DILAUDID INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1926-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:c88f81ac-1643-4c08-ae2c-63cbe956db7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897655
  • 897653
  • 1724354
  • 1724357
  • 1724276
  • 1724352
  • 1724339
  • 897753
  • 897747
  • 897755

    • Pharmacological Class

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

    NDC Crossover Matching brand name "DILAUDID" or generic name "Hydromorphone Hydrochloride"

    NDCBrand NameGeneric Name
    70399-102DILAUDIDDILAUDID
    76045-009DilaudidDilaudid
    76045-010DilaudidDilaudid
    42858-122DilaudidDilaudid
    42858-416DilaudidDilaudid
    42858-338DilaudidDilaudid
    42858-234DilaudidDilaudid
    55154-1610DilaudidDilaudid
    59011-442DILAUDIDDILAUDID
    59011-444DILAUDIDDILAUDID
    59011-452DILAUDIDDILAUDID
    59011-458DILAUDIDDILAUDID
    59011-451DILAUDIDDILAUDID
    59011-454DILAUDIDDILAUDID
    65084-440DILAUDIDDILAUDID
    76045-121DilaudidDilaudid
    0054-0264Hydromorphone Hydrochloridehydromorphone hydrochloride
    0054-0265Hydromorphone Hydrochloridehydromorphone hydrochloride
    0054-0386Hydromorphone Hydrochloridehydromorphone hydrochloride
    0406-3243Hydromorphone Hydrochloridehydromorphone hydrochloride
    0406-3244Hydromorphone Hydrochloridehydromorphone hydrochloride
    0406-3249Hydromorphone Hydrochloridehydromorphone hydrochloride
    0406-3308Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0406-3312Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0406-3316Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0406-3332Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDE

    Trademark Results [DILAUDID]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DILAUDID
    DILAUDID
    71327970 0298197 Live/Registered
    E. BILHUBER, INC.
    1932-06-14
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