imipenem and cilastatin (63323-349)

Drug Facts

Product Profile

Brand Name imipenem and cilastatin

Generic Name imipenem and cilastatin sodium

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

cilastatin sodium 250 mg/20mL, imipenem 250 mg/20mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-349

Product ID 63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090577

Listing Expiration 2026-12-31

Marketing Start 2012-01-03

Pharmacologic Class

Classes

carbapenems [cs] dipeptidase inhibitors [moa] penem antibacterial [epc] renal dehydropeptidase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323349

Hyphenated Format 63323-349

Supplemental Identifiers

RxCUI

1726204

UPC

0363323349011 0363323322014

UNII

5428WXZ74M 71OTZ9ZE0A

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 sodium (source: ndc)

Application Number ANDA090577 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

250 mg/20mL

source: ndc

Packaging

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01)

source: ndc

Packages (1)

63323-349-25 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01)

Ingredients (2)

cilastatin sodium (250 mg/20mL) imipenem (250 mg/20mL)

Linked Drug Pages (3)

Imipenem and Cilastatin ndc-match (0.9) Imipenem and Cilastatin ndc-match (0.9) Imipenem and Cilastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "2bb9b6ad-8e8d-4667-b108-b57a8c16318f", "openfda": {"upc": ["0363323349011", "0363323322014"], "unii": ["5428WXZ74M", "71OTZ9ZE0A"], "rxcui": ["1726204"], "spl_set_id": ["6ab0ca9e-9a79-4cab-9f09-470eda06952e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01)", "package_ndc": "63323-349-25", "marketing_start_date": "20120103"}], "brand_name": "Imipenem and Cilastatin", "product_id": "63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Dipeptidase Inhibitors [MoA]", "Penem Antibacterial [EPC]", "Renal Dehydropeptidase Inhibitor [EPC]"], "product_ndc": "63323-349", "generic_name": "Imipenem and Cilastatin Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imipenem and Cilastatin", "active_ingredients": [{"name": "CILASTATIN SODIUM", "strength": "250 mg/20mL"}, {"name": "IMIPENEM", "strength": "250 mg/20mL"}], "application_number": "ANDA090577", "marketing_category": "ANDA", "marketing_start_date": "20120103", "listing_expiration_date": "20261231"}