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NDC 00409-3613-01 Bupivacaine 7.5 mg/mL Details
Bupivacaine 7.5 mg/mL
Bupivacaine is a SUBARACHNOID INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is BUPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 00409-3613 |
|---|---|
| Product ID | 0409-3613_cd32bbaa-7714-458e-8855-50ae146cfcaa |
| Associated GPIs | 69100010112010 |
| GCN Sequence Number | 052199 |
| GCN Sequence Number Description | bupivacaine HCl in dextrose/PF AMPUL 0.75 % INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 19768 |
| HICL Sequence Number | 025245 |
| HICL Sequence Number Description | BUPIVACAINE HCL IN DEXTROSE/PF |
| Brand/Generic | Generic |
| Proprietary Name | Bupivacaine |
| Proprietary Name Suffix | Spinal |
| Non-Proprietary Name | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBARACHNOID |
| Active Ingredient Strength | 7.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE |
| Labeler Name | Hospira, Inc. |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA071810 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00409-3613-01 (00409361301)
| NDC Package Code | 0409-3613-01 |
|---|---|
| Billing NDC | 00409361301 |
| Package | 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11) |
| Marketing Start Date | 2005-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |