NDC 50383-287

Buprenorphine and Naloxone

Buprenorphine Hydrochloride And Naloxone Hydrochloride

Buprenorphine and Naloxone is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co. Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

Product ID50383-287_227f24a8-176d-432e-a5f8-3644e91a19d6
NDC50383-287
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine and Naloxone
Generic NameBuprenorphine Hydrochloride And Naloxone Hydrochloride
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2016-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA204431
Labeler NameHi-Tech Pharmacal Co. Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
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 Through2021-12-31

Packaging

NDC 50383-287-93

30 TABLET in 1 BOTTLE, PLASTIC (50383-287-93)
Marketing Start Date2016-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-287-33 [50383028733]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA204431
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01
Marketing End Date2017-12-22

NDC 50383-287-93 [50383028793]

Buprenorphine and Naloxone TABLET
Marketing CategoryANDA
Application NumberANDA204431
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-01-07

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]

Medicade Reported Pricing

50383028793 BUPRENORPHINE-NALOXONE 8-2 MG SL TABLET

Pricing Unit: EA | Drug Type:

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

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.