NDC 0406-3312

Hydromorphone Hydrochloride Extended-Release

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Hydromorphone Hydrochloride.

Product ID0406-3312_123d99b6-2d52-4491-944c-f73b9d6387b8
NDC0406-3312
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride Extended-Release
Generic NameHydromorphone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-06-12
Marketing End Date2021-03-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021217
Labeler NameSpecGx LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength12 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0406-3312-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3312-01)
Marketing Start Date2014-05-16
Marketing End Date2021-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-3312-01 [00406331201]

Hydromorphone Hydrochloride Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-12
Marketing End Date2021-03-31

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE12 mg/1

OpenFDA Data

SPL SET ID:0f522b18-ce6d-4fc7-8bc7-5b2ea2dd3840
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1306898
  • 902736
  • 902741
  • 902729
    • UPC Code
  • 0304063308012
  • 0304063316017
  • 0304063332017
  • 0304063312019

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Hydromorphone Hydrochloride Extended-Release" 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.