NDC 62175-458

Buprenorphine and Naloxone

Buprenorphine And Naloxone

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

Product ID62175-458_10858687-fe38-4f32-9dfc-6b1c50896259
NDC62175-458
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2016-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA205022
Labeler NameLannett Company, Inc.
Substance NameBUPRENORPHINE; NALOXONE
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 Through2020-12-31

Packaging

NDC 62175-458-32

30 TABLET in 1 BOTTLE (62175-458-32)
Marketing Start Date2016-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62175-458-32 [62175045832]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA205022
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-19

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE8 mg/1

OpenFDA Data

SPL SET ID:14eaa94a-cc8a-4e1e-8cfb-5c976c96c606
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266
    • UPC Code
  • 0362175452320

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    0781-7216BUPRENORPHINE AND NALOXONEbuprenorphine hydrochloride, naloxone hydrochloride
    0781-7249BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7227BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    0781-7238BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONE
    43598-579Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-580Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-582Buprenorphine and NaloxoneBuprenorphine and Naloxone
    43598-581Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-294Buprenorphine and NaloxoneBuprenorphine and Naloxone
    50383-287Buprenorphine and NaloxoneBuprenorphine and Naloxone
    53217-138Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-587Buprenorphine and NaloxoneBuprenorphine and Naloxone
    60429-586Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-452Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-969Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62175-458Buprenorphine and NaloxoneBuprenorphine and Naloxone
    62756-970Buprenorphine and NaloxoneBuprenorphine and Naloxone
    63629-7270Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2327Buprenorphine and NaloxoneBuprenorphine and Naloxone
    70518-2311Buprenorphine and NaloxoneBuprenorphine and Naloxone
    0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.