NDC 68387-531

Pentazocine and naloxone

Pentazocine Hydrochloride And Naloxone Hydrochloride

Pentazocine and naloxone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Pentazocine Hydrochloride; Naloxone Hydrochloride.

Product ID68387-531_49cd8e11-2282-4c5b-bb4f-95526a9e2d6b
NDC68387-531
Product TypeHuman Prescription Drug
Proprietary NamePentazocine and naloxone
Generic NamePentazocine Hydrochloride And Naloxone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-21
Marketing CategoryANDA / ANDA
Application NumberANDA074736
Labeler NameKeltman Pharmaceuticals Inc.
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]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-531-12

120 TABLET in 1 BOTTLE, PLASTIC (68387-531-12)
Marketing Start Date2009-07-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-531-12 [68387053112]

Pentazocine and naloxone TABLET
Marketing CategoryANDA
Application NumberANDA074736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-21
Inactivation Date2019-10-21

NDC 68387-531-60 [68387053160]

Pentazocine and naloxone TABLET
Marketing CategoryANDA
Application NumberANDA074736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-21
Inactivation Date2019-10-21

NDC 68387-531-30 [68387053130]

Pentazocine and naloxone TABLET
Marketing CategoryANDA
Application NumberANDA074736
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-21
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
PENTAZOCINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:05a17f16-c982-4a54-80cd-079959ab49a7
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 and naloxone" or generic name "Pentazocine Hydrochloride And Naloxone Hydrochloride"

    NDCBrand NameGeneric Name
    0591-0395Pentazocine and naloxonePentazocine hydrochloride and naloxone hydrochloride
    63304-506pentazocine and naloxonepentazocine and naloxone
    68387-531Pentazocine and naloxonePENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
    43386-680PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEpentazocine hydrochloride and naloxone hydrochloride
    61919-556PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
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