NDC 60505-6196

Ertapenem

Ertapenem Sodium

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

Product ID60505-6196_84aa159c-5372-4712-e053-2a91aa0a1a07
NDC60505-6196
Product TypeHuman Prescription Drug
Proprietary NameErtapenem
Generic NameErtapenem Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2019-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA207647
Labeler NameApotex Corp
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/20mL
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60505-6196-4

10 VIAL in 1 CARTON (60505-6196-4) > 20 mL in 1 VIAL (60505-6196-0)
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6196-0 [60505619600]

Ertapenem INJECTION
Marketing CategoryANDA
Application NumberANDA207647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-02

NDC 60505-6196-4 [60505619604]

Ertapenem INJECTION
Marketing CategoryANDA
Application NumberANDA207647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-02

Drug Details

Active Ingredients

IngredientStrength
ERTAPENEM SODIUM1 g/20mL

OpenFDA Data

SPL SET ID:468105b9-48b3-4477-82c7-e7fb92460e28
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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