NDC 0781-3098

MEROPENEM

Meropenem

MEROPENEM is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Meropenem.

Product ID0781-3098_313c6444-c110-400c-9532-bd5a02555ebd
NDC0781-3098
Product TypeHuman Prescription Drug
Proprietary NameMEROPENEM
Generic NameMeropenem
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA206086
Labeler NameSandoz Inc
Substance NameMEROPENEM
Active Ingredient Strength1 g/30mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-3098-95

10 VIAL in 1 CARTON (0781-3098-95) > 30 mL in 1 VIAL (0781-3098-94)
Marketing Start Date2016-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3098-95 [00781309895]

MEROPENEM INJECTION
Marketing CategoryANDA
Application NumberANDA206086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-29

NDC 0781-3098-94 [00781309894]

MEROPENEM INJECTION
Marketing CategoryANDA
Application NumberANDA206086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-29

NDC 0781-3098-96 [00781309896]

MEROPENEM INJECTION
Marketing CategoryANDA
Application NumberANDA206086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-29

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM1 g/30mL

OpenFDA Data

SPL SET ID:0d37e43b-ff8d-495d-b9af-4fd5fce53d56
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.