Imipenem and Cilastatin

Product NDC

0409-3507

11-digit product format

004093507

Labeler code

0409

Product ID

0409-3507_ad96cecb-40e9-4197-809d-0788fe641543

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Imipenem and Cilastatin

Dosage form

INJECTION, POWDER, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Hospira, Inc.

Application

ANDA090825

Marketing category

ANDA

Marketing start

2011-11-16

Marketing end

0000-00-00

Substance

IMIPENEM; CILASTATIN SODIUM

Active strength

500 mg/100mL; mg/100mL

Pharmacologic classes

Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record