NDC 70518-2311

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 Remedyrepack Inc.. The primary component is Buprenorphine; Naloxone.

Product ID70518-2311_92a16990-5252-3d3b-e053-2a95a90a94e5
NDC70518-2311
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2019-09-12
Marketing CategoryANDA / ANDA
Application NumberANDA205022
Labeler NameREMEDYREPACK 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 70518-2311-0

30 TABLET in 1 BLISTER PACK (70518-2311-0)
Marketing Start Date2019-09-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2311-0 [70518231100]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA205022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-12

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE8 mg/1

OpenFDA Data

SPL SET ID:e69bcd0d-a394-4bba-90d3-2ad40f3fb55e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • Pharmacological Class

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