NDC 76045-009

Dilaudid

Hydromorphone Hydrochloride

Dilaudid is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Hydromorphone Hydrochloride.

Product ID76045-009_5a28aca5-35d9-4e7b-b3e2-91c4611ee020
NDC76045-009
Product TypeHuman Prescription Drug
Proprietary NameDilaudid
Generic NameHydromorphone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-12-04
Marketing CategoryNDA / NDA
Application NumberNDA019034
Labeler NameFresenius Kabi USA, LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76045-009-06

10 SYRINGE in 1 CARTON (76045-009-06) > .5 mL in 1 SYRINGE (76045-009-96)
Marketing Start Date2018-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76045-009-05 [76045000905]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-16

NDC 76045-009-11 [76045000911]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-04

NDC 76045-009-10 [76045000910]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-16

NDC 76045-009-96 [76045000996]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-04

NDC 76045-009-00 [76045000900]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

NDC 76045-009-03 [76045000903]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

NDC 76045-009-06 [76045000906]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-04

NDC 76045-009-01 [76045000901]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-12-04

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:4d77772f-874f-9c87-2d80-ca467c7690a1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1872265
  • 1433251
  • 1872269
  • 1872752
  • 897756
  • 897757

    • Pharmacological Class

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