NDC 42291-174

Buprenorphine HCl and Naloxone HCl

Buprenorphine And Naloxone

Buprenorphine HCl and Naloxone HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID42291-174_7cb2a8b6-2817-7781-e053-2a91aa0aaf16
NDC42291-174
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl and Naloxone HCl
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-04-02
Marketing CategoryANDA / ANDA
Application NumberANDA203136
Labeler NameAvKARE, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength2 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-174-30

30 TABLET in 1 BOTTLE (42291-174-30)
Marketing Start Date2013-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-174-30 [42291017430]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-02
Marketing End Date2019-11-30

NDC 42291-174-90 [42291017490]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-02
Marketing End Date2013-09-30

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:88b8da23-ed89-e90f-2743-a4efae08f22e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine HCl and Naloxone HCl" or generic name "Buprenorphine And Naloxone"

    NDCBrand NameGeneric Name
    0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    42291-175Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    50268-145Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    50268-144Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    65162-415Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    65162-416Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
    0228-3154Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0228-3155Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8765Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8766Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0378-8767Buprenorphine and Naloxonebuprenorphine and naloxone
    0378-8768Buprenorphine and Naloxonebuprenorphine and naloxone
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