NDC 16714-889

ERTAPENEM SODIUM

Ertapenem

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

Product ID16714-889_575e9b37-5113-58cd-8190-bed6b30b6172
NDC16714-889
Product TypeHuman Prescription Drug
Proprietary NameERTAPENEM SODIUM
Generic NameErtapenem
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2021-07-13
Marketing CategoryANDA /
Application NumberANDA212040
Labeler NameNorthStar RxLLC
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS], Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 16714-889-10

10 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01)
Marketing Start Date2021-07-13
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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

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