NDC 63323-508

Meropenem

Meropenem

Meropenem is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Meropenem.

Product ID63323-508_144ce05a-6636-484c-98d7-95e365caa4a0
NDC63323-508
Product TypeHuman Prescription Drug
Proprietary NameMeropenem
Generic NameMeropenem
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA091404
Labeler NameFresenius Kabi USA, LLC
Substance NameMEROPENEM
Active Ingredient Strength1 g/20mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-508-31

10 VIAL in 1 CARTON (63323-508-31) > 20 mL in 1 VIAL
Marketing Start Date2011-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-508-25 [63323050825]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-26

NDC 63323-508-30 [63323050830]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-26

NDC 63323-508-31 [63323050831]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-26

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM1 g/20mL

OpenFDA Data

SPL SET ID:7a68d899-2678-43a9-a9c1-ef8f916b562f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1722934
  • 1722939
  • Pharmacological Class

    • Carbapenems [CS]
    • Penem Antibacterial [EPC]

    NDC Crossover Matching brand name "Meropenem" or generic name "Meropenem"

    NDCBrand NameGeneric Name
    0409-0222MeropenemMeropenem
    0409-1390MeropenemMeropenem
    0409-1391MeropenemMeropenem
    0409-3412MeropenemMeropenem
    0409-3505MeropenemMEROPENEM
    0409-3506MeropenemMEROPENEM
    0781-3000MEROPENEMMEROPENEM
    0781-3098MEROPENEMMEROPENEM
    0781-3265MeropenemMeropenem
    0781-3267MeropenemMeropenem
    25021-155Meropenemmeropenem
    25021-156Meropenemmeropenem
    44567-145MeropenemMeropenem
    68001-324MeropenemMeropenem
    68001-323MeropenemMeropenem
    68083-147MeropenemMeropenem
    68083-146MeropenemMeropenem
    70278-103MeropenemMeropenem
    70121-1453MeropenemMeropenem
    70121-1454MeropenemMeropenem
    70278-104MeropenemMeropenem
    44647-032MEROPENEMMEROPENEM
    44647-033MEROPENEMMEROPENEM
    55150-208MeropenemMeropenem
    55150-207MeropenemMeropenem
    63323-508MeropenemMeropenem
    63323-507MeropenemMeropenem
    0069-0313MERREMMeropenem
    0069-0314MERREMMeropenem
    0310-0321MERREMMeropenem
    0310-0325MERREMMeropenem

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