NDC 61919-556

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Pentazocine Hydrochloride And Naloxone Hydrochloride

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Pentazocine Hydrochloride; Naloxone Hydrochloride.

Product ID61919-556_40f9338f-419e-19a8-e054-00144ff8d46c
NDC61919-556
Product TypeHuman Prescription Drug
Proprietary NamePENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Generic NamePentazocine Hydrochloride And Naloxone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA075735
Labeler NameDIRECT RX
Substance NamePENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesCompetitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-556-30

30 TABLET in 1 BOTTLE (61919-556-30)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-556-30 [61919055630]

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA075735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
PENTAZOCINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:0967a6ed-138c-4465-9d81-fea67c00749b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312289
  • Pharmacological Class

    • Competitive Opioid Antagonists [MoA]
    • Partial Opioid Agonist/Antagonist [EPC]
    • Partial Opioid Agonists [MoA]
    • Opioid Antagonist [EPC]
    • Opioid Antagonists [MoA]

    NDC Crossover Matching brand name "PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE" or generic name "Pentazocine Hydrochloride And Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    43386-680PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEpentazocine hydrochloride and naloxone hydrochloride
    61919-556PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
    0591-0395Pentazocine and naloxonePentazocine hydrochloride and naloxone hydrochloride
    68387-531Pentazocine and naloxonePENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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