NDC 0143-9398

ertapenem sodium

Ertapenem Sodium

ertapenem sodium is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa, Inc.. The primary component is Ertapenem Sodium.

Product ID0143-9398_a400707f-763f-43f6-989e-0d2569d822d8
NDC0143-9398
Product TypeHuman Prescription Drug
Proprietary Nameertapenem sodium
Generic NameErtapenem Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2021-08-02
Marketing CategoryANDA /
Application NumberANDA208790
Labeler NameHikma Pharmaceuticals USA, Inc.
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0143-9398-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)
Marketing Start Date2021-08-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ertapenem sodium" or generic name "Ertapenem Sodium"

NDCBrand NameGeneric Name
0143-9398ertapenem sodiumertapenem sodium
16714-889ERTAPENEM SODIUMErtapenem
43598-901ERTAPENEM SODIUMErtapenem
44567-820ertapenem sodiumertapenem sodium
42023-221ERTAPENEMertapenem sodium
44647-051ErtapenemErtapenem Sodium
60505-6196ErtapenemErtapenem Sodium
63323-823ErtapenemErtapenem Sodium
68001-408ErtapenemErtapenem Sodium
68083-351ErtapenemErtapenem Sodium
72266-159ErtapenemErtapenem Sodium
0006-3843INVANZertapenem sodium

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