NDC 68083-351

Ertapenam

Ertapenam Sodium

Ertapenam is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Ertapenem Sodium.

Product ID68083-351_3fc764db-934e-4ead-8a75-51f640f8bcee
NDC68083-351
Product TypeHuman Prescription Drug
Proprietary NameErtapenam
Generic NameErtapenam Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2021-03-26
Marketing CategoryANDA /
Application NumberANDA212040
Labeler NameGland Pharma Limited
Substance NameERTAPENEM SODIUM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68083-351-10

10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)
Marketing Start Date2021-03-26
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Ertapenam" or generic name "Ertapenam Sodium"

NDCBrand NameGeneric Name
68083-351ErtapenamErtapenam Sodium
72266-159ErtapenamErtapenam Sodium

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