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NDC 70594-0114-02 Bupivacaine HCl 2.5 mg/mL Details
Bupivacaine HCl 2.5 mg/mL
Bupivacaine HCl is a EPIDURAL; INTRACAUDAL; PERINEURAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Xellia Pharmaceuticals USA LLC. The primary component is BUPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 70594-0114 |
|---|---|
| Product ID | 70594-114_afc179ac-71b9-4021-8b71-3372bf590e4a |
| Associated GPIs | |
| GCN Sequence Number | 052193 |
| GCN Sequence Number Description | bupivacaine HCl/PF VIAL 2.5 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 19757 |
| HICL Sequence Number | 025243 |
| HICL Sequence Number Description | BUPIVACAINE HCL/PF |
| Brand/Generic | Generic |
| Proprietary Name | Bupivacaine HCl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bupivacaine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | EPIDURAL; INTRACAUDAL; PERINEURAL |
| Active Ingredient Strength | 2.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE |
| Labeler Name | Xellia Pharmaceuticals USA LLC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091487 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70594-0114-02 (70594011402)
| NDC Package Code | 70594-114-02 |
|---|---|
| Billing NDC | 70594011402 |
| Package | 10 VIAL in 1 CARTON (70594-114-02) / 10 mL in 1 VIAL (70594-114-01) |
| Marketing Start Date | 2023-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |