NDC 0591-3631

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Hydromorphone Hydrochloride.

Product ID0591-3631_58056dce-d482-4c10-abaf-6ecfd9f4f976
NDC0591-3631
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride
Generic NameHydromorphone Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-10-10
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA202144
Labeler NameActavis Pharma, Inc.
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength32 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0591-3631-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3631-01)
Marketing Start Date2016-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3631-01 [00591363101]

Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-10
Marketing End Date2019-08-31

NDC 0591-3631-10 [00591363110]

Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202144
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-10
Marketing End Date2016-10-10

NDC 0591-3631-30 [00591363130]

Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202144
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-10
Marketing End Date2016-10-10

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE32 mg/1

OpenFDA Data

SPL SET ID:5a717315-250b-4e2d-b315-3ae1b6c337f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1306898
  • 902736
  • 902741
  • 902729
    • UPC Code
  • 0305913631304

    • 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.