NDC 42858-601

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 Rhodes Pharmaceuticals L.p.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID42858-601_1ed5b53e-ca98-415b-987a-3bff477a6472
NDC42858-601
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2020-04-13
Marketing CategoryANDA / ANDA
Application NumberANDA205601
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength2 mg/1; mg/1
Pharm ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42858-601-03

30 TABLET in 1 BOTTLE, PLASTIC (42858-601-03)
Marketing Start Date2020-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42858-601-03 [42858060103]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA205601
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-13

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:794724a6-0fba-bc8d-ecdb-9e3be8ea2191
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 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
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