BUPRENORPHINE 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.
| Product ID | 71335-1154_3063a7e3-f858-4b29-9ff8-237473414f8c |
| NDC | 71335-1154 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BUPRENORPHINE |
| Generic Name | Buprenorphine |
| Dosage Form | Tablet |
| Route of Administration | SUBLINGUAL |
| Marketing Start Date | 2017-10-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207276 |
| Labeler Name | Bryant Ranch Prepack |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Active Ingredient Strength | 8 mg/1 |
| Pharm Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-03-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA207276 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-03-21 |
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
| SPL SET ID: | a7da638f-f590-4577-bff9-15a91c6e7917 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-3239 | Buprenorphine | Buprenorphine |
| 0093-3600 | Buprenorphine | Buprenorphine |
| 0093-3601 | Buprenorphine | Buprenorphine |
| 0093-3602 | Buprenorphine | Buprenorphine |
| 0093-3603 | Buprenorphine | Buprenorphine |
| 0093-3656 | Buprenorphine | Buprenorphine |
| 0093-3657 | Buprenorphine | Buprenorphine |
| 0093-3658 | Buprenorphine | Buprenorphine |
| 0093-3659 | Buprenorphine | Buprenorphine |
| 0228-3153 | Buprenorphine | Buprenorphine |
| 0228-3156 | Buprenorphine | Buprenorphine |
| 70518-0711 | Buprenorphine | Buprenorphine |
| 70518-1557 | Buprenorphine | Buprenorphine |
| 70518-1625 | Buprenorphine | Buprenorphine |
| 71335-0353 | Buprenorphine | Buprenorphine |
| 71335-0950 | BUPRENORPHINE | BUPRENORPHINE |
| 42858-586 | Buprenorphine | Buprenorphine |
| 42858-750 | Buprenorphine | Buprenorphine |
| 42858-502 | BUPRENORPHINE | BUPRENORPHINE |
| 42858-501 | BUPRENORPHINE | BUPRENORPHINE |
| 42858-353 | Buprenorphine | Buprenorphine |
| 42858-839 | Buprenorphine | Buprenorphine |
| 42858-493 | Buprenorphine | Buprenorphine |
| 50090-2924 | Buprenorphine | Buprenorphine |
| 55700-579 | Buprenorphine | Buprenorphine |
| 55700-568 | Buprenorphine | Buprenorphine |
| 58118-3156 | Buprenorphine | Buprenorphine |
| 62756-459 | Buprenorphine | Buprenorphine |
| 62756-460 | Buprenorphine | Buprenorphine |
| 67046-994 | Buprenorphine | Buprenorphine |
| 67046-995 | Buprenorphine | Buprenorphine |
| 71335-1154 | BUPRENORPHINE | BUPRENORPHINE |
| 70518-2218 | BUPRENORPHINE | BUPRENORPHINE |
| 70518-2217 | BUPRENORPHINE | BUPRENORPHINE |