NDC 65162-415

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 Amneal Pharmaceuticals Llc. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID65162-415_4b35aa6c-df87-4dd1-a4b5-efbe99197c33
NDC65162-415
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 NameAmneal Pharmaceuticals LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength8 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 Through2022-12-31

Packaging

NDC 65162-415-03

30 TABLET in 1 BOTTLE (65162-415-03)
Marketing Start Date2013-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-415-09 [65162041509]

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

NDC 65162-415-03 [65162041503]

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

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:17b63f10-c9df-44be-80fa-6f1c305583b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266
    • UPC Code
  • 0365162416039
  • 0365162415032

    • Pharmacological Class

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

    Medicade Reported Pricing

    65162041503 BUPRENORPHINE-NALOXONE 8-2 MG SL TABLET

    Pricing Unit: EA | Drug Type:

    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.