NDC 23635-416

EXALGO

Hydromorphone Hydrochloride

EXALGO 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 ID23635-416_0cc967c3-2f93-438b-a25c-0a4bbaf4f313
NDC23635-416
Product TypeHuman Prescription Drug
Proprietary NameEXALGO
Generic NameHydromorphone Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-03-01
Marketing End Date2021-04-30
Marketing CategoryNDA / NDA
Application NumberNDA021217
Labeler NameSpecGx LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength16 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 23635-416-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23635-416-01)
Marketing Start Date2010-03-01
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23635-416-01 [23635041601]

EXALGO TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021217
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-01
Marketing End Date2021-04-30

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE16 mg/1

OpenFDA Data

SPL SET ID:22e635cb-98c0-e4f9-6a71-62d7487a0a6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1306900
  • 902738
  • 902729
  • 1306898
  • 902736
  • 902733
  • 902741
  • 902743
  • UPC Code
  • 0323635412018
  • 0323635408011
  • 0323635432016
  • 0323635416016
  • Pharmacological Class

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

    Medicade Reported Pricing

    23635041601 EXALGO ER 16 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "EXALGO" or generic name "Hydromorphone Hydrochloride"

    NDCBrand NameGeneric Name
    23635-432EXALGOEXALGO
    23635-416EXALGOEXALGO
    23635-412EXALGOEXALGO
    23635-408EXALGOEXALGO
    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

    Trademark Results [EXALGO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXALGO
    EXALGO
    87542359 5406796 Live/Registered
    SPECGX LLC
    2017-07-25
    EXALGO
    EXALGO
    77605306 3822640 Dead/Cancelled
    MALLINCKRODT INC.
    2008-10-31

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