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NDC 00143-9335-10 Bupivacaine Hydrochloride 7.5 mg/mL Details
Bupivacaine Hydrochloride 7.5 mg/mL
Bupivacaine Hydrochloride is a EPIDURAL; RETROBULBAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is BUPIVACAINE HYDROCHLORIDE.
Product Information
| NDC | 00143-9335 |
|---|---|
| Product ID | 0143-9335_70fe2b6d-7eaf-4507-8ba0-b07e84b775cb |
| Associated GPIs | 69100010102018 |
| GCN Sequence Number | 052195 |
| GCN Sequence Number Description | bupivacaine HCl/PF VIAL 7.5 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 19759 |
| HICL Sequence Number | 025243 |
| HICL Sequence Number Description | BUPIVACAINE HCL/PF |
| 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 | EPIDURAL; RETROBULBAR |
| Active Ingredient Strength | 7.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204842 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9335-10 (00143933510)
| NDC Package Code | 0143-9335-10 |
|---|---|
| Billing NDC | 00143933510 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9335-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9335-01) |
| Marketing Start Date | 2021-02-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |