NDC 71335-0759

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 ID71335-0759_a6a055a3-739f-44ee-a89c-1df46bc7b961
NDC71335-0759
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride
Generic NameHydromorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA076855
Labeler NameBryant Ranch Prepack
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0759-1

25 TABLET in 1 BOTTLE (71335-0759-1)
Marketing Start Date2018-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0759-4 [71335075904]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-6 [71335075906]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-2 [71335075902]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-8 [71335075908]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-5 [71335075905]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-7 [71335075907]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-1 [71335075901]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-3 [71335075903]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

NDC 71335-0759-9 [71335075909]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA076855
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-02

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:2064e143-dbf7-4a69-9b42-4763227f22ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897696
  • 897710

    • 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.