NDC 43598-580

Buprenorphine and Naloxone

Buprenorphine And Naloxone

Buprenorphine and Naloxone is a Buccal; Sublingual Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Dr.reddys Laboratories Inc. The primary component is Buprenorphine Hydrochloride; Naloxone.

Product ID43598-580_2c3ab1f7-8554-d026-665d-67ac3e080b8a
NDC43598-580
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormFilm, Soluble
Route of AdministrationBUCCAL; SUBLINGUAL
Marketing Start Date2018-06-14
Marketing CategoryANDA / ANDA
Application NumberANDA205806
Labeler NameDr.Reddys Laboratories Inc
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE
Active Ingredient Strength4 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 43598-580-30

30 POUCH in 1 CARTON (43598-580-30) > 1 FILM, SOLUBLE in 1 POUCH (43598-580-01)
Marketing Start Date2018-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-580-30 [43598058030]

Buprenorphine and Naloxone FILM, SOLUBLE
Marketing CategoryANDA
Application NumberANDA205806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-14

NDC 43598-580-01 [43598058001]

Buprenorphine and Naloxone FILM, SOLUBLE
Marketing CategoryANDA
Application NumberANDA205806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-14

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1307061
  • 1307056
    • UPC Code
  • 0343598580012

    • 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.