NDC 55150-282

Ertapenem

Ertapenem

Ertapenem is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Ertapenem Sodium.

Product ID55150-282_12dac88d-50eb-4166-90df-45baf31dbe7e
NDC55150-282
Product TypeHuman Prescription Drug
Proprietary NameErtapenem
Generic NameErtapenem
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA209133
Labeler NameAuroMedics Pharma LLC
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55150-282-09

10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-09) > 1 INJECTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-282-20 [55150028220]

Ertapenem INJECTION
Marketing CategoryANDA
Application NumberANDA209133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-25

NDC 55150-282-09 [55150028209]

Ertapenem INJECTION
Marketing CategoryANDA
Application NumberANDA209133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-25

Drug Details

Active Ingredients

IngredientStrength
ERTAPENEM SODIUM1 g/1

OpenFDA Data

SPL SET ID:f725a68c-31a2-482a-9744-19adc47506b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734683
  • Pharmacological Class

    • Carbapenems [CS]
    • Penem Antibacterial [EPC]

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

    NDCBrand NameGeneric Name
    0409-3510ErtapenemErtapenem
    42023-221ERTAPENEMertapenem sodium
    44567-820ertapenemertapenem
    44647-051ErtapenemErtapenem Sodium
    55150-282ErtapenemErtapenem
    60505-6196ErtapenemErtapenem Sodium
    63323-823ErtapenemErtapenem Sodium
    68001-408ErtapenemErtapenem Sodium
    68083-351ErtapenemErtapenem Sodium
    16714-889ERTAPENEM SODIUMErtapenem
    43598-901ERTAPENEM SODIUMErtapenem

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