Imipenem and Cilastatin is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Imipenem; Cilastatin Sodium.
| Product ID | 0409-3507_ad96cecb-40e9-4197-809d-0788fe641543 |
| NDC | 0409-3507 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Imipenem and Cilastatin |
| Generic Name | Imipenem And Cilastatin |
| Dosage Form | Injection, Powder, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2011-11-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090825 |
| Labeler Name | Hospira, Inc. |
| Substance Name | IMIPENEM; CILASTATIN SODIUM |
| Active Ingredient Strength | 500 mg/100mL; mg/100mL |
| Pharm Classes | Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2011-11-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-03-19 |
| Marketing End Date | 2017-07-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-11-17 |
| Marketing End Date | 2016-03-31 |
| Marketing Category | ANDA |
| Application Number | ANDA091007 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-11-17 |
| Marketing End Date | 2011-11-17 |
| Marketing Category | ANDA |
| Application Number | ANDA091007 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-08-01 |
| Marketing End Date | 2011-11-17 |
| Marketing Category | ANDA |
| Application Number | ANDA090825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-11-16 |
| Marketing End Date | 2017-07-31 |
| Marketing Category | ANDA |
| Application Number | ANDA090825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-11-17 |
| Marketing End Date | 2016-03-31 |
| Ingredient | Strength |
|---|---|
| IMIPENEM | 500 mg/100mL |
| SPL SET ID: | fe44d24d-55cd-439c-895b-00a38cd59f65 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-3507 | Imipenem and Cilastatin | Imipenem and Cilastatin |
| 0409-3508 | Imipenem and Cilastatin | Imipenem and Cilastatin |
| 44567-705 | Imipenem and Cilastatin | Imipenem and Cilastatin |
| 63323-322 | Imipenem and Cilastatin | Imipenem and Cilastatin Sodium |
| 63323-349 | Imipenem and Cilastatin | Imipenem and Cilastatin Sodium |