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NDC 00409-9045-01 Bupivacaine Hydrochloride and Epinephrine 5; 5 mg/mL; ug/mL Details
Bupivacaine Hydrochloride and Epinephrine 5; 5 mg/mL; ug/mL
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 Information
| NDC | 00409-9045 |
|---|---|
| Product ID | 0409-9045_832b49a9-8fed-4b1b-bf60-c330520ef46a |
| Associated GPIs | 69991002102017 |
| GCN Sequence Number | 052188 |
| GCN Sequence Number Description | bupivacaine HCl/epinephrine/PF VIAL 0.5-1:200K INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 19752 |
| HICL Sequence Number | 025242 |
| HICL Sequence Number Description | BUPIVACAINE HCL/EPINEPHRINE/PF |
| Brand/Generic | Generic |
| Proprietary Name | Bupivacaine Hydrochloride and Epinephrine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | EPIDURAL; INTRACAUDAL; PERINEURAL |
| Active Ingredient Strength | 5; 5 |
| Active Ingredient Units | mg/mL; ug/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Labeler Name | Hospira, Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA071168 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00409-9045-01 (00409904501)
| NDC Package Code | 0409-9045-01 |
|---|---|
| Billing NDC | 00409904501 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9045-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9045-11) |
| Marketing Start Date | 2005-09-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |