NDC 65084-440

DILAUDID

Hydromorphone Hydrochloride

DILAUDID is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mckesson Rxpak Inc. The primary component is Hydromorphone Hydrochloride.

Product ID65084-440_41858c95-2f6b-4e6f-b2ad-c7c2e1068d43
NDC65084-440
Product TypeHuman Prescription Drug
Proprietary NameDILAUDID
Generic NameHydromorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1956-01-01
Marketing CategoryNDA / NDA
Application NumberNDA019892
Labeler NameMckesson Rxpak Inc
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65084-440-10

100 TABLET in 1 BOTTLE (65084-440-10)
Marketing Start Date2009-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65084-440-10 [65084044010]

DILAUDID TABLET
Marketing CategoryNDA
Application NumberNDA019892
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-05-12
Marketing End Date2019-09-05

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:ac5982ec-4ece-4b10-9613-db50203f4524
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897704
  • 897702

    • 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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