NDC 71335-1514

Buprenorphine HCl and Naloxone HCl

Buprenorphine And Naloxone

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

Product ID71335-1514_bcd4d6a2-e186-4557-9e26-3989e03269b5
NDC71335-1514
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl and Naloxone HCl
Generic NameBuprenorphine And Naloxone
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-02-22
Marketing CategoryANDA / ANDA
Application NumberANDA203136
Labeler NameBryant Ranch Prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength2 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 71335-1514-1

30 TABLET in 1 BOTTLE (71335-1514-1)
Marketing Start Date2020-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1514-1 [71335151401]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

NDC 71335-1514-2 [71335151402]

Buprenorphine HCl and Naloxone HCl TABLET
Marketing CategoryANDA
Application NumberANDA203136
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

Drug Details

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

NDCBrand NameGeneric Name
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and Naloxone
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine HCl and Naloxone HCl
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.