Product NDC: | 63323-322 |
Proprietary Name: | Imipenem and Cilastatin |
Non Proprietary Name: | Imipenem and Cilastatin Sodium |
Active Ingredient(s): | 500; 500 mg/1; mg/1 & nbsp; Imipenem and Cilastatin Sodium |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-322 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090577 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120103 |
Package NDC: | 63323-322-25 |
Package Description: | 25 VIAL, GLASS in 1 CARTON (63323-322-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
NDC Code | 63323-322-25 |
Proprietary Name | Imipenem and Cilastatin |
Package Description | 25 VIAL, GLASS in 1 CARTON (63323-322-25) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
Product NDC | 63323-322 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Imipenem and Cilastatin Sodium |
Dosage Form Name | INJECTION, POWDER, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20120103 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | CILASTATIN SODIUM; IMIPENEM |
Strength Number | 500; 500 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] |