NDC 63323-507

Meropenem

Meropenem

Meropenem is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Meropenem.

• Product ID: 63323-507_144ce05a-6636-484c-98d7-95e365caa4a0
• NDC: 63323-507
• Product Type: Human Prescription Drug
• Proprietary Name: Meropenem
• Generic Name: Meropenem
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-10-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091404
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: MEROPENEM
• Active Ingredient Strength: 500 mg/10mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63323-507-21

10 VIAL in 1 CARTON (63323-507-21) > 10 mL in 1 VIAL

• Marketing Start Date: 2011-10-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-507-21 [63323050721]

Meropenem INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091404
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-14

NDC 63323-507-20 [63323050720]

Meropenem INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091404
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-14

NDC 63323-507-25 [63323050725]

Meropenem INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091404
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-14

Drug Details

Active Ingredients

Ingredient	Strength
MEROPENEM	500 mg/10mL

OpenFDA Data

• SPL SET ID: 185181e3-c004-4d61-b992-5df94fe57a90
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • FV9J3JU8B1
• RxNorm Concept Unique ID - RxCUI:
  • 1722934
  • 1722939

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]

NDC Crossover Matching brand name "Meropenem" or generic name "Meropenem"

NDC	Brand Name	Generic Name
0409-0222	Meropenem	Meropenem
0409-1390	Meropenem	Meropenem
0409-1391	Meropenem	Meropenem
0409-3412	Meropenem	Meropenem
0409-3505	Meropenem	MEROPENEM
0409-3506	Meropenem	MEROPENEM
0781-3000	MEROPENEM	MEROPENEM
0781-3098	MEROPENEM	MEROPENEM
0781-3265	Meropenem	Meropenem
0781-3267	Meropenem	Meropenem
25021-155	Meropenem	meropenem
25021-156	Meropenem	meropenem
44567-145	Meropenem	Meropenem
68001-324	Meropenem	Meropenem
68001-323	Meropenem	Meropenem
68083-147	Meropenem	Meropenem
68083-146	Meropenem	Meropenem
70278-103	Meropenem	Meropenem
70121-1453	Meropenem	Meropenem
70121-1454	Meropenem	Meropenem
70278-104	Meropenem	Meropenem
44647-032	MEROPENEM	MEROPENEM
44647-033	MEROPENEM	MEROPENEM
55150-208	Meropenem	Meropenem
55150-207	Meropenem	Meropenem
63323-508	Meropenem	Meropenem
63323-507	Meropenem	Meropenem
0069-0313	MERREM	Meropenem
0069-0314	MERREM	Meropenem
0310-0321	MERREM	Meropenem
0310-0325	MERREM	Meropenem