Buprenorphine Hydrochloride Sublingual is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Buprenorphine Hydrochloride.
| Product ID | 0378-0923_140de61a-37dc-465e-a4c6-35b605b918a8 |
| NDC | 0378-0923 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Buprenorphine Hydrochloride Sublingual |
| Generic Name | Buprenorphine Hydrochloride Sublingual |
| Dosage Form | Tablet |
| Route of Administration | SUBLINGUAL |
| Marketing Start Date | 2015-03-06 |
| Marketing End Date | 2019-10-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201066 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Marketing Start Date | 2015-03-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201066 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-03-06 |
| Marketing End Date | 2019-10-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201066 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-06 |
| Marketing End Date | 2016-04-15 |
| Marketing Category | ANDA |
| Application Number | ANDA201066 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-03-06 |
| Marketing End Date | 2016-04-15 |
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
| SPL SET ID: | 7a85f424-9d83-49d9-8a17-478abce6fddd |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-0923 | Buprenorphine Hydrochloride Sublingual | buprenorphine hydrochloride sublingual |
| 0378-0924 | Buprenorphine Hydrochloride Sublingual | buprenorphine hydrochloride sublingual |
| 67046-996 | Buprenorphine Hydrochloride Sublingual | buprenorphine hydrochloride sublingual |
| 67046-997 | Buprenorphine Hydrochloride Sublingual | buprenorphine hydrochloride sublingual |
| 70518-0652 | Buprenorphine Hydrochloride Sublingual | buprenorphine hydrochloride sublingual |