NDC 71335-0723

HYDROMORPHONE HYDROCHLORIDE

Hydromorphone Hydrochloride

HYDROMORPHONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Hydromorphone Hydrochloride.

Product ID71335-0723_29765ff0-3b1d-47da-953e-28bf0e6a56ef
NDC71335-0723
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 NameBryant Ranch Prepack
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0723-0

90 TABLET in 1 BOTTLE (71335-0723-0)
Marketing Start Date2018-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0723-3 [71335072303]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-0 [71335072300]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-4 [71335072304]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-5 [71335072305]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-8 [71335072308]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-6 [71335072306]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-7 [71335072307]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-1 [71335072301]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-13

NDC 71335-0723-2 [71335072302]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 71335-0723-9 [71335072309]

HYDROMORPHONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA205814
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:29765ff0-3b1d-47da-953e-28bf0e6a56ef
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897696
  • 897702
  • 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

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