NDC 63323-823

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 Fresenius Kabi Usa, Llc. The primary component is Ertapenem Sodium.

• Product ID: 63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafb
• NDC: 63323-823
• Product Type: Human Prescription Drug
• Proprietary Name: Ertapenem
• Generic Name: Ertapenem Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-10-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208790
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: ERTAPENEM SODIUM
• Active Ingredient Strength: 1 g/1
• Pharm Classes: Carbapenems [CS], Penem Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63323-823-20

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)

• Marketing Start Date: 2019-10-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-823-20 [63323082320]

Ertapenem INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA208790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-10-10

NDC 63323-823-01 [63323082301]

Ertapenem INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA208790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-10-10

Drug Details

Active Ingredients

Ingredient	Strength
ERTAPENEM SODIUM	1 g/1

OpenFDA Data

• SPL SET ID: 666c9f33-ea9e-4667-b8bd-f8b1b6b6be51
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 2T90KE67L0
• RxNorm Concept Unique ID - RxCUI:
  • 1734683

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

NDC	Brand Name	Generic Name
0409-3510	Ertapenem	Ertapenem
42023-221	ERTAPENEM	ertapenem sodium
44567-820	ertapenem	ertapenem
44647-051	Ertapenem	Ertapenem Sodium
55150-282	Ertapenem	Ertapenem
60505-6196	Ertapenem	Ertapenem Sodium
63323-823	Ertapenem	Ertapenem
68001-408	Ertapenem	Ertapenem
0143-9398	ertapenem sodium	ertapenem sodium
16714-889	ERTAPENEM SODIUM	Ertapenem
43598-901	ERTAPENEM SODIUM	Ertapenem
0006-3843	INVANZ	ertapenem sodium