NDC 63323-853

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride 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 ID63323-853_44293e7e-486d-4fc9-bcd0-7046b1f9f5df
NDC63323-853
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride
Generic NameHydromorphone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2017-12-15
Marketing CategoryNDA / NDA
Application NumberNDA019034
Labeler NameFresenius Kabi USA, LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-853-25

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-853-25) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-853-03)
Marketing Start Date2017-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-853-25 [63323085325]

Hydromorphone Hydrochloride INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-15

NDC 63323-853-03 [63323085303]

Hydromorphone Hydrochloride INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-15

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:e034eb96-03e0-46e1-8b92-5e1f94555e7b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897653
  • 1724340
  • 1724341
  • 1724276
  • 1724338
  • 897753

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0409-3459Hydromorphone HydrochlorideHydromorphone Hydrochloride
    68084-472Hydromorphone HydrochlorideHydromorphone Hydrochloride
    68084-423Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0527-1355Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0527-1353Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0527-1354Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0574-0293hydromorphone hydrochloridehydromorphone hydrochloride
    0574-0295hydromorphone hydrochloridehydromorphone hydrochloride
    0574-0294hydromorphone hydrochloridehydromorphone hydrochloride
    0574-0297hydromorphone hydrochloridehydromorphone hydrochloride
    70166-250Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0574-7224HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    0591-3631Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0591-3630Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0591-3629Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0591-3739Hydromorphone HydrochlorideHydromorphone Hydrochloride
    71335-0229HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    71335-0265Hydromorphone HydrochlorideHydromorphone Hydrochloride
    71335-0887HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    71335-0233Hydromorphone HydrochlorideHydromorphone Hydrochloride
    71335-0723HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    71335-0303Hydromorphone HydrochlorideHydromorphone Hydrochloride
    71335-0759Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0641-0121Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0641-6151Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0641-2341Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0703-0110Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0703-0018Hydromorphone HydrochlorideHydromorphone Hydrochloride
    0703-0113Hydromorphone HydrochlorideHydromorphone Hydrochloride
    13107-107HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    13107-109HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    13107-108HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
    13811-701Hydromorphone HydrochlorideHydromorphone Hydrochloride
    13811-703Hydromorphone HydrochlorideHydromorphone Hydrochloride
    13811-702Hydromorphone HydrochlorideHydromorphone Hydrochloride
    13811-704Hydromorphone HydrochlorideHydromorphone Hydrochloride
    17478-540Hydromorphone HydrochlorideHydromorphone Hydrochloride
    17856-0386Hydromorphone HydrochlorideHydromorphone Hydrochloride
    35356-815Hydromorphone HydrochlorideHydromorphone Hydrochloride
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