NDC 42023-221

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 Par Pharmaceutical Inc.. The primary component is Ertapenem Sodium.

• Product ID: 42023-221_3304b702-daf2-48ac-950e-2ae613398ee1
• NDC: 42023-221
• 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: 2018-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA021337
• Labeler Name: Par Pharmaceutical Inc.
• Substance Name: ERTAPENEM SODIUM
• Active Ingredient Strength: 1 g/1
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 42023-221-85

10 VIAL, SINGLE-DOSE in 1 TRAY (42023-221-85) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89)

• Marketing Start Date: 2018-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42023-221-01 [42023022101]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021337
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-26

NDC 42023-221-89 [42023022189]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021337
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-01

NDC 42023-221-85 [42023022185]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021337
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-01

NDC 42023-221-10 [42023022110]

ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021337
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-26

Drug Details

Active Ingredients

Ingredient	Strength
ERTAPENEM SODIUM	1 g/1

OpenFDA Data

• SPL SET ID: 657855f2-7c92-4aa8-9c3d-51d08e56a09a
• Manufacturer:
  • Par Pharmaceutical Inc.
• UNII:
  • 2T90KE67L0
• RxNorm Concept Unique ID - RxCUI:
  • 1734683

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]

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