NDC 0409-3505

Meropenem

Meropenem

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

Product ID0409-3505_10e1a10f-a4a1-46de-b235-81efbe39b9e4
NDC0409-3505
Product TypeHuman Prescription Drug
Proprietary NameMeropenem
Generic NameMeropenem
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA090940
Labeler NameHospira, Inc.
Substance NameMEROPENEM
Active Ingredient Strength500 mg/10mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0409-3505-01

25 VIAL in 1 CARTON (0409-3505-01) > 10 mL in 1 VIAL (0409-3505-11)
Marketing Start Date2010-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-3505-01 [00409350501]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-24
Marketing End Date2019-05-31

NDC 0409-3505-11 [00409350511]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-01
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM500 mg/10mL

OpenFDA Data

SPL SET ID:a27ce7d2-0b75-47e8-9a7e-1e561b603216
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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