| NDC Code | 68083-351-10 |
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| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01) |
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| Product NDC | 68083-351 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Ertapenem |
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| Non-Proprietary Name | Ertapenem Sodium |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAMUSCULAR; INTRAVENOUS |
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| Start Marketing Date | 20210326 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA212040 |
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| Manufacturer | Gland Pharma Limited |
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| Substance Name | ERTAPENEM SODIUM |
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| Strength | 1 |
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| Strength Unit | g/1 |
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| Pharmacy Classes | Carbapenems [CS], Penem Antibacterial [EPC] |
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