NDC 71335-1378

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 Bryant Ranch Prepack. The primary component is Buprenorphine; Naloxone.

Product ID71335-1378_2af8cc3e-a916-436e-89a1-c8d1893deb0f
NDC71335-1378
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 NameBryant Ranch Prepack
Substance NameBUPRENORPHINE; NALOXONE
Active Ingredient Strength8 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 71335-1378-0

42 TABLET in 1 BOTTLE (71335-1378-0)
Marketing Start Date2022-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1378-1 [71335137801]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA205022
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

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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