NDC 43386-670

Pentazocine Hydrochloride and Acetaminophen

Pentazocine Hydrochloride And Acetaminophen

Pentazocine Hydrochloride and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Gavis Pharmaceuticals, Llc. The primary component is Pentazocine Hydrochloride; Acetaminophen.

Product ID43386-670_fc01cb97-4b1c-4f4f-baed-401357b05489
NDC43386-670
Product TypeHuman Prescription Drug
Proprietary NamePentazocine Hydrochloride and Acetaminophen
Generic NamePentazocine Hydrochloride And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-05-11
Marketing CategoryANDA / ANDA
Application NumberANDA076202
Labeler NameGAVIS Pharmaceuticals, LLC
Substance NamePENTAZOCINE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesCompetitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43386-670-01

100 TABLET in 1 BOTTLE (43386-670-01)
Marketing Start Date2011-05-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-670-01 [43386067001]

Pentazocine Hydrochloride and Acetaminophen TABLET
Marketing CategoryANDA
Application NumberANDA076202
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-05-11
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
PENTAZOCINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:62a055f3-a58b-446d-9476-af6d36956eaf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312288
  • Pharmacological Class

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

    Medicade Reported Pricing

    43386067001 PENTAZOCIN-ACETAMINOPHN 25-650

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Pentazocine Hydrochloride and Acetaminophen" or generic name "Pentazocine Hydrochloride And Acetaminophen"

    NDCBrand NameGeneric Name
    43386-670Pentazocine Hydrochloride and AcetaminophenPentazocine Hydrochloride and Acetaminophen
    21695-634Pentazocine HCl and AcetaminophenPentazocine Hydrochloride and Acetaminophen

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