Buprenorphine HCl and Naloxone HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.
Product ID | 50268-145_76b83519-b5b1-3847-e053-2991aa0a68ef |
NDC | 50268-145 |
Product Type | Human Prescription Drug |
Proprietary Name | Buprenorphine HCl and Naloxone HCl |
Generic Name | Buprenorphine And Naloxone |
Dosage Form | Tablet |
Route of Administration | SUBLINGUAL |
Marketing Start Date | 2016-12-08 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA203136 |
Labeler Name | AvPAK |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
Active Ingredient Strength | 8 mg/1; mg/1 |
Pharm Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
DEA Schedule | CIII |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2016-12-08 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA203136 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2016-12-08 |
Marketing End Date | 2018-09-25 |
Marketing Category | ANDA |
Application Number | ANDA203136 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-12-08 |
Marketing Category | ANDA |
Application Number | ANDA203136 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-12-08 |
Ingredient | Strength |
---|---|
BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
SPL SET ID: | b955054b-b37d-4079-4fed-5939b763ecb4 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0406-1923 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |
0406-1924 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |
42291-174 | Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone |
70518-1007 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
70518-1684 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
42291-175 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
50268-145 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
50268-144 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
65162-415 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
65162-416 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
71335-1514 | Buprenorphine HCl and Naloxone HCl | Buprenorphine HCl and Naloxone HCl |
0228-3154 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
0228-3155 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
0378-8765 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
0378-8766 | Buprenorphine and Naloxone | Buprenorphine and Naloxone |
0378-8767 | Buprenorphine and Naloxone | buprenorphine and naloxone |
0378-8768 | Buprenorphine and Naloxone | buprenorphine and naloxone |