NDC 35356-816

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Hydromorphone Hydrochloride.

Product ID35356-816_21554c87-8e58-410a-9f31-3200a5b91d28
NDC35356-816
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride
Generic NameHydromorphone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-09
Marketing CategoryANDA / ANDA
Application NumberANDA078439
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 35356-816-30

30 TABLET in 1 BOTTLE, PLASTIC (35356-816-30)
Marketing Start Date2009-12-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-816-30 [35356081630]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-09

NDC 35356-816-60 [35356081660]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-09

NDC 35356-816-90 [35356081690]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-09
Marketing End Date2009-12-31

NDC 35356-816-01 [35356081601]

Hydromorphone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA078439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-09
Marketing End Date2009-12-31

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:efc12b44-69ef-4d03-b9bb-09a934eb81c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897696
  • 897710
  • 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.