| Product NDC: | 59630-320 |
| Proprietary Name: | Doribax |
| Non Proprietary Name: | doripenem |
| Active Ingredient(s): | 500 mg/10mL & nbsp; doripenem |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | POWDER, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59630-320 |
| Labeler Name: | Shionogi Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022106 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101015 |
| Package NDC: | 59630-320-50 |
| Package Description: | 48 CASE in 1 CONTAINER (59630-320-50) > 228 VIAL, SINGLE-USE in 1 CASE > 10 mL in 1 VIAL, SINGLE-USE (59630-320-01) |
| NDC Code | 59630-320-50 |
| Proprietary Name | Doribax |
| Package Description | 48 CASE in 1 CONTAINER (59630-320-50) > 228 VIAL, SINGLE-USE in 1 CASE > 10 mL in 1 VIAL, SINGLE-USE (59630-320-01) |
| Product NDC | 59630-320 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | doripenem |
| Dosage Form Name | POWDER, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20101015 |
| Marketing Category Name | NDA |
| Labeler Name | Shionogi Inc. |
| Substance Name | DORIPENEM |
| Strength Number | 500 |
| Strength Unit | mg/10mL |
| Pharmaceutical Classes | Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] |