NDC 70278-103

Meropenem

Meropenem

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

Product ID70278-103_7e0d8e57-8865-4f4a-e053-2a91aa0a8c59
NDC70278-103
Product TypeHuman Prescription Drug
Proprietary NameMeropenem
Generic NameMeropenem
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA204854
Labeler NameDaewoong America Inc.
Substance NameMEROPENEM
Active Ingredient Strength500 mg/20mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70278-103-02

10 VIAL in 1 CARTON (70278-103-02) > 20 mL in 1 VIAL (70278-103-01)
Marketing Start Date2016-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70278-103-01 [70278010301]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-08

NDC 70278-103-02 [70278010302]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-08

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM500 mg/20mL

OpenFDA Data

SPL SET ID:ee58bb66-26b8-4dc5-a029-d6df324495cd
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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