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NDC 71288-0726-52 bupivacaine hydrochloride 5 mg/mL Details
bupivacaine hydrochloride 5 mg/mL
bupivacaine hydrochloride is a PERINEURAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc. The primary component is BUPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 71288-0726 |
|---|---|
| Product ID | 71288-726_0949c302-51ce-4fc9-8b99-1df94e693718 |
| Associated GPIs | |
| GCN Sequence Number | 003359 |
| GCN Sequence Number Description | bupivacaine HCl VIAL 5 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 11701 |
| HICL Sequence Number | 001470 |
| HICL Sequence Number Description | BUPIVACAINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | bupivacaine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | bupivacaine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | PERINEURAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE |
| Labeler Name | Meitheal Pharmaceuticals Inc |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216039 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0726-52 (71288072652)
| NDC Package Code | 71288-726-52 |
|---|---|
| Billing NDC | 71288072652 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-726-52) / 50 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2023-06-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |