Bupivacaine Hydrochloride and Epinephrine is a Epidural; Intracaudal; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.
| Product ID | 0409-9045_22d17a49-609f-4c2b-aaf0-f0ab712529ba |
| NDC | 0409-9045 |
| 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; INTRACAUDAL; PERINEURAL |
| Marketing Start Date | 2005-05-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA071168 |
| Labeler Name | Hospira, Inc. |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Active Ingredient Strength | 5 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 | 2020-12-31 |
| Marketing Start Date | 2005-09-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-08-05 |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-05-18 |
| Marketing End Date | 2012-05-01 |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-08-05 |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-21 |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-08-05 |
| Marketing End Date | 2016-10-18 |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-09-08 |
| Ingredient | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 5 mg/mL |
| SPL SET ID: | 02a845c3-4521-4926-e397-25ab536e7cf6 |
| 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 |