NDC 0406-8005

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID0406-8005_55ab91e0-8108-45b4-b4ba-4d6d395a9e83
NDC0406-8005
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Generic NameBuprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA207000
Labeler NameSpecGx LLC
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0406-8005-03

30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03)
Marketing Start Date2017-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-8005-03 [00406800503]

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate TABLET
Marketing CategoryANDA
Application NumberANDA207000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-13

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:62abde41-46cb-4e90-a798-23d6531bf9aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351267
  • 351266
  • UPC Code
  • 0304068005039
  • 0304068020032
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    0904-7009buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    16729-549BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    16729-550BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
    71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
    71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
    71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate

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