Bupivacaine Hydrochloride and Epinephrine is a Epidural; Infiltration; Intracaudal; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.
| Product ID | 52584-042_799eebf4-53cc-404f-bd27-9857b2471cb3 |
| NDC | 52584-042 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Bupivacaine Hydrochloride and Epinephrine |
| Generic Name | Bupivacaine Hydrochloride And Epinephrine |
| Dosage Form | Injection, Solution |
| Route of Administration | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Marketing Start Date | 2010-07-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA071165 |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Active Ingredient Strength | 3 mg/mL; ug/mL |
| Pharm Classes | Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2016-09-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA071165 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-07-01 |
| Marketing End Date | 2017-01-16 |
| Marketing Category | ANDA |
| Application Number | ANDA071165 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-09-22 |
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
| SPL SET ID: | fab28f67-9dfa-4bf7-8758-c0c4b6aef56a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0404-9828 | Bupivacaine Hydrochloride and Epinephrine | Bupivacaine Hydrochloride and Epinephrine |
| 0409-9042 | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | bupivacaine hydrochloride and epinephrine |
| 0409-9043 | Bupivacaine Hydrochloride and Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-9045 | Bupivacaine Hydrochloride and Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-9046 | Bupivacaine Hydrochloride and Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 52584-042 | Bupivacaine Hydrochloride and Epinephrine | Bupivacaine Hydrochloride and Epinephrine |
| 0409-1541 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-3812 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-4208 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-5738 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-6581 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-8126 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |