NDC 70399-102

DILAUDID

Hydromorphone Hydrochloride

DILAUDID is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by V1 Pharma Llc. The primary component is Hydromorphone Hydrochloride.

Product ID70399-102_260324cf-7851-4d90-ab35-5f71bc5104b0
NDC70399-102
Product TypeHuman Prescription Drug
Proprietary NameDILAUDID
Generic NameHydromorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA076723
Labeler NameV1 Pharma Llc
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70399-102-50

100 TABLET in 1 BOTTLE (70399-102-50)
Marketing Start Date2017-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70399-102-50 [70399010250]

DILAUDID TABLET
Marketing CategoryANDA
Application NumberANDA076723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:3129ab18-7cd8-4c65-b3b1-ed0c8c1fdc00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897712
  • 897710
    • UPC Code
  • 0370399102501

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.