NDC 0406-1923

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 Mallinckrodt, Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID0406-1923_0070df14-2e60-47ac-887f-37333fb185f7
NDC0406-1923
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl and Naloxone HCl
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA203136
Labeler NameMallinckrodt, 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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0406-1923-03

30 TABLET in 1 BOTTLE (0406-1923-03)
Marketing Start Date2013-02-22
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-1923-09 [00406192309]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-22
Marketing End Date2019-10-16

NDC 0406-1923-03 [00406192303]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-22
Marketing End Date2021-02-28

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:5b438c05-68d8-4d3c-84ce-375c0667e4bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266
    • UPC Code
  • 0304061923095
  • 0304061924092

    • 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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