NDC 42858-416

Dilaudid

Hydromorphone Hydrochloride

Dilaudid is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Hydromorphone Hydrochloride.

Product ID42858-416_181500cd-4770-444c-8822-848b64b749ba
NDC42858-416
Product TypeHuman Prescription Drug
Proprietary NameDilaudid
Generic NameHydromorphone Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-05-15
Marketing CategoryNDA / NDA
Application NumberNDA019891
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42858-416-16

473 mL in 1 BOTTLE, PLASTIC (42858-416-16)
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42858-416-16 [42858041616]

Dilaudid SOLUTION
Marketing CategoryNDA
Application NumberNDA019891
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:d6b40e39-a57e-402c-b4f6-7041e832f837
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897657
  • 897658
  • 897704
  • 897712
  • 897696
  • 897710
  • 897702
  • 897698
  • Pharmacological Class

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

    Medicade Reported Pricing

    42858041616 DILAUDID 5 MG/5 ML ORAL LIQUID

    Pricing Unit: ML | Drug Type:

    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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