MARCAINE WITH 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 | 52584-746_4ba01ae9-9296-4ab5-a60e-0e5c516c73e2 |
| NDC | 52584-746 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MARCAINE WITH EPINEPHRINE |
| Generic Name | Bupivacaine Hydrochloride And Epinephrine Bitartrate |
| Dosage Form | Injection, Solution |
| Route of Administration | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Marketing Start Date | 2019-11-04 |
| Marketing Category | NDA / NDA |
| Application Number | NDA016964 |
| Labeler Name | General Injectables & Vaccines, Inc. |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Active Ingredient Strength | 3 mg/mL; mg/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 | 2020-12-31 |
| Marketing Start Date | 2019-11-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA016964 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-11-04 |
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 2.5 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0404-9908 | MARCAINE WITH EPINEPHRINE | bupivacaine hydrochloride and epinephrine bitartrate |
| 0409-1541 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| 0409-1746 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
| 0409-1749 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
| 0409-1752 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
| 0409-1755 | Marcaine with Epinephrine | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
| 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 |
| 52584-746 | MARCAINE WITH EPINEPHRINE | MARCAINE WITH EPINEPHRINE |
| 0362-0557 | Marcaine | bupivacaine hydrochloride and epinephrine bitartrate |
| 0362-9011 | Vivacaine | bupivacaine hydrochloride and epinephrine bitartrate |