imipenem and cilastatin (44567-705)

Drug Facts

Product Profile

Brand Name imipenem and cilastatin

Generic Name imipenem and cilastatin

Labeler wg critical care, llc

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

cilastatin sodium 500 mg/1, imipenem anhydrous 500 mg/1

Manufacturer

WG Critical Care, LLC

Identifiers & Regulatory

Product NDC 44567-705

Product ID 44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207594

Listing Expiration 2026-12-31

Marketing Start 2021-03-09

Pharmacologic Class

Established (EPC)

penem antibacterial [epc]

Chemical Structure

carbapenems [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44567705

Hyphenated Format 44567-705

Supplemental Identifiers

RxCUI

1726214

UPC

0344567705016

UNII

5428WXZ74M Q20IM7HE75

NUI

M0024174 N0000175496

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imipenem and cilastatin (source: ndc)

Generic Name imipenem and cilastatin (source: ndc)

Application Number ANDA207594 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

500 mg/1

source: ndc

Packaging

10 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

source: ndc

Packages (1)

44567-705-10 10 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (2)

cilastatin sodium (500 mg/1) imipenem anhydrous (500 mg/1)

Linked Drug Pages (1)

Imipenem and Cilastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "6bfcc077-8c32-4c7e-abaa-f17eb2084231", "openfda": {"nui": ["M0024174", "N0000175496"], "upc": ["0344567705016"], "unii": ["5428WXZ74M", "Q20IM7HE75"], "rxcui": ["1726214"], "spl_set_id": ["46f54df9-5afe-430c-aa19-0d84c2044b0b"], "pharm_class_cs": ["Carbapenems [CS]"], "pharm_class_epc": ["Penem Antibacterial [EPC]"], "manufacturer_name": ["WG Critical Care, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (44567-705-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "44567-705-10", "marketing_start_date": "20210309"}], "brand_name": "Imipenem and Cilastatin", "product_id": "44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Dipeptidase Inhibitors [MoA]", "Penem Antibacterial [EPC]", "Renal Dehydropeptidase Inhibitor [EPC]"], "product_ndc": "44567-705", "generic_name": "Imipenem and Cilastatin", "labeler_name": "WG Critical Care, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipenem and Cilastatin", "active_ingredients": [{"name": "CILASTATIN SODIUM", "strength": "500 mg/1"}, {"name": "IMIPENEM ANHYDROUS", "strength": "500 mg/1"}], "application_number": "ANDA207594", "marketing_category": "ANDA", "marketing_start_date": "20210309", "listing_expiration_date": "20261231"}