meropenem

Generic: meropenem

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meropenem
Generic Name meropenem
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

meropenem 1 g/20mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-508
Product ID 63323-508_8fe3d813-4656-49d6-ad91-6a075f3d3a82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091404
Listing Expiration 2026-12-31
Marketing Start 2011-10-26

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323508
Hyphenated Format 63323-508

Supplemental Identifiers

RxCUI
1722934 1722939
UNII
FV9J3JU8B1

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 meropenem (source: ndc)
Generic Name meropenem (source: ndc)
Application Number ANDA091404 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/20mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (63323-508-25) / 20 mL in 1 VIAL (63323-508-45)
source: ndc

Packages (1)

63323-508-25 25 VIAL in 1 CARTON (63323-508-25) / 20 mL in 1 VIAL (63323-508-45)

Ingredients (1)

meropenem (1 g/20mL)

Linked Drug Pages (3)

Meropenem ndc-match (0.9) Meropenem ndc-match (0.9) Meropenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8fe3d813-4656-49d6-ad91-6a075f3d3a82", "openfda": {"unii": ["FV9J3JU8B1"], "rxcui": ["1722934", "1722939"], "spl_set_id": ["7a68d899-2678-43a9-a9c1-ef8f916b562f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (63323-508-25)  / 20 mL in 1 VIAL (63323-508-45)", "package_ndc": "63323-508-25", "marketing_start_date": "20111026"}], "brand_name": "Meropenem", "product_id": "63323-508_8fe3d813-4656-49d6-ad91-6a075f3d3a82", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "63323-508", "generic_name": "Meropenem", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meropenem", "active_ingredients": [{"name": "MEROPENEM", "strength": "1 g/20mL"}], "application_number": "ANDA091404", "marketing_category": "ANDA", "marketing_start_date": "20111026", "listing_expiration_date": "20261231"}