NDC 42023-221

ERTAPENEM

Ertapenem Sodium

ERTAPENEM is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical Inc.. The primary component is Ertapenem Sodium.

Product ID42023-221_3304b702-daf2-48ac-950e-2ae613398ee1
NDC42023-221
Product TypeHuman Prescription Drug
Proprietary NameERTAPENEM
Generic NameErtapenem Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-11-01
Marketing CategoryNDA / NDA
Application NumberNDA021337
Labeler NamePar Pharmaceutical Inc.
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42023-221-85

10 VIAL, SINGLE-DOSE in 1 TRAY (42023-221-85) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42023-221-01 [42023022101]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021337
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-26

NDC 42023-221-89 [42023022189]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021337
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 42023-221-85 [42023022185]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021337
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 42023-221-10 [42023022110]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021337
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-26

Drug Details

Active Ingredients

IngredientStrength
ERTAPENEM SODIUM1 g/1

OpenFDA Data

SPL SET ID:657855f2-7c92-4aa8-9c3d-51d08e56a09a
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 Sodium"

    NDCBrand NameGeneric Name
    0409-3510ErtapenemErtapenem
    42023-221ERTAPENEMertapenem sodium
    44567-820ertapenemertapenem
    44647-051ErtapenemErtapenem Sodium
    55150-282ErtapenemErtapenem
    60505-6196ErtapenemErtapenem Sodium
    63323-823ErtapenemErtapenem
    68001-408ErtapenemErtapenem
    0143-9398ertapenem sodiumertapenem sodium
    16714-889ERTAPENEM SODIUMErtapenem
    43598-901ERTAPENEM SODIUMErtapenem
    0006-3843INVANZertapenem sodium

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