| NDC Code | 70529-005-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-005-01) > 30 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 70529-005 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Durapren 0.5% |
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| Non-Proprietary Name | Bupivacaine Hydrochloride |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | EPIDURAL; INTRACAUDAL; PERINEURAL |
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| Start Marketing Date | 20170301 |
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| Marketing Category Name | NDA |
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| Application Number | NDA016964 |
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| Manufacturer | IT3 Medical LLC |
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| Substance Name | BUPIVACAINE HYDROCHLORIDE |
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| Strength | 5 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE] |
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