NDC 0228-3154

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 Actavis Pharma, Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID0228-3154_00163875-879b-4fe0-9a38-143a58bb8993
NDC0228-3154
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2015-10-01
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA091422
Labeler NameActavis Pharma, Inc.
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 Through2020-12-31

Packaging

NDC 0228-3154-03

30 TABLET in 1 BOTTLE (0228-3154-03)
Marketing Start Date2013-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0228-3154-03 [00228315403]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA091422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-13

NDC 0228-3154-73 [00228315473]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA091422
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-01
Marketing End Date2020-12-31

NDC 0228-3154-09 [00228315409]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA091422
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01
Marketing End Date2016-10-25

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

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.