NDC 68083-147

Meropenem

Meropenem

Meropenem is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Meropenem.

Product ID68083-147_8b03ee4b-3dac-413f-aa72-4ec7f0fe5a4a
NDC68083-147
Product TypeHuman Prescription Drug
Proprietary NameMeropenem
Generic NameMeropenem
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-04-28
Marketing CategoryANDA / ANDA
Application NumberANDA206141
Labeler NameGland Pharma Limited
Substance NameMEROPENEM
Active Ingredient Strength1 g/30mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-147-10

10 VIAL in 1 CARTON (68083-147-10) > 30 mL in 1 VIAL
Marketing Start Date2017-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-147-10 [68083014710]

Meropenem INJECTION
Marketing CategoryANDA
Application NumberANDA206141
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-28

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM1 g/30mL

OpenFDA Data

SPL SET ID:4e4e2c0c-df54-4229-ab90-fa671ecedd57
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1722934
  • 1722939
  • UPC Code
  • 0368083146016
  • 0368083147013
  • 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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