NDC 13107-108

HYDROMORPHONE HYDROCHLORIDE

Hydromorphone Hydrochloride

HYDROMORPHONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma, Llc. The primary component is Hydromorphone Hydrochloride.

Product ID13107-108_6c358f23-c07d-4b3a-9844-5366d5fa158d
NDC13107-108
Product TypeHuman Prescription Drug
Proprietary NameHYDROMORPHONE HYDROCHLORIDE
Generic NameHydromorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA205814
Labeler NameAurolife Pharma, LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 13107-108-01

100 TABLET in 1 BOTTLE (13107-108-01)
Marketing Start Date2016-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-108-99 [13107010899]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-17

NDC 13107-108-20 [13107010820]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-17

NDC 13107-108-01 [13107010801]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-17

NDC 13107-108-05 [13107010805]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-17

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:f778dfab-e109-428e-b1b7-4dfb1b8293e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897696
  • 897710
  • 897702
  • Pharmacological Class

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

    Medicade Reported Pricing

    13107010801 HYDROMORPHONE 4 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

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