NDC 63323-507-43 - Meropenem

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63323-507
Requested NDC: 63323-507-43
Package NDCs from labels: 63323-507-19, 63323-507-21, 63323-507-43, 63323-507-25, 63323-507-01, 63323-507-20
Manufacturer: Fresenius Kabi USA, LLC | ACS Dobfar S.p.A. | Zambon Switzerland Ltd
Effective date: 2021-03-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Meropenem - Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL
Meropenem - Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	2021-03-10	HUMAN PRESCRIPTION DRUG LABEL
Meropenem - Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	Fresenius Kabi USA, LLC \| ACS Dobfar S.p.A. \| Zambon Switzerland Ltd	2020-10-19	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-507-19	Meropenem	10 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	10	16
63323-507-21	Meropenem	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	16
63323-507-01	Meropenem	10 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	10	15
63323-507-20	Meropenem	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	15
63323-507-25	Meropenem	25 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	25	11
63323-507-43	Meropenem	10 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	10	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-507	MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	16	Current NDC, Legacy NDC, 2 package rows	20210317_12714f80-d6e5-4453-b66c-62f57c16ddfc.zip
63323-507	MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	15	Current NDC, Legacy NDC, 2 package rows	20210310_185181e3-c004-4d61-b992-5df94fe57a90.zip
63323-507	MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20210316_7a68d899-2678-43a9-a9c1-ef8f916b562f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-507-01	EA - Each	63323-507	321fad89-ec91-4ad9-b2ac-997a43e07000	1	2022-02-07
63323-507-19	EA - Each	63323-507	6a7006db-9032-4cd3-b56e-f212b63a9723	1	2026-02-05
63323-507-20	EA - Each	63323-507	f953ac5f-8c3d-4763-872a-d6ddb14d6a0f	1	2012-07-24
63323-507-21	EA - Each	63323-507	9009ebdc-77de-4985-9030-c0d4ae278728	1	2013-03-03
63323-507-25	EA - Each	63323-507	2e82be56-fe76-48de-8880-577c544c7e5b	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	8
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	8
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	5
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	5
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Hikma Pharmaceuticals USA Inc.	8a2a545e-b336-416a-be73-9e0a7ccf6177	2026-08-26	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Sagent Pharmaceuticals	e8848f4a-bca9-4978-b0a1-38483fd4d639	2026-03-31	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
VABOMERE	MEROPENEM-VABORBACTAM	Melinta Therapeutics, LLC	e237fd0f-3050-42a3-b43e-b6fb4824e93d	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: FV9J3JU8B1
Meropenem	MEROPENEM	BluePoint Laboratories	ca5f501c-6520-4d09-aae2-4f5db74d468f	2025-12-12	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
MEROPENEM	MEROPENEM	Sandoz Inc	0d37e43b-ff8d-495d-b9af-4fd5fce53d56	2025-11-14	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Qilu Antibiotics Pharmaceutical Co., Ltd.	1f9591ed-3a6c-422e-b1be-7b3e4fe5bf3c	2025-09-16	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Civica, Inc.	35466216-55ed-4836-8cbc-c8aafb079dae	2025-09-12	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem and Sodium Chloride	MEROPENEM AND SODIUM CHLORIDE	B. Braun Medical Inc.	3b952a55-6ef7-45c8-be21-16eefe37ec2e	2025-08-05	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	BROOKS STERISCIENCE LIMITED	58e165b7-e230-4459-abf9-06d5ca1dd7b2	2025-07-31	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Eugia US LLC	bf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c	2025-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Gland Pharma Limited	4e4e2c0c-df54-4229-ab90-fa671ecedd57	2025-06-26	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Amneal Pharmaceuticals LLC	a456013b-b20e-4b29-b2f9-06f18f1ea6bd	2025-06-09	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Hikma Pharmaceuticals USA Inc.	d54fdbad-ca93-467c-92d7-c1bd88f3bbe3	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Hospira, Inc.	e9b6555f-20a1-4415-bb80-3d034cfab95b	2024-11-06	Warnings, Adverse reactions	Exact identifier application number: ANDA091404 rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Hospira, Inc.	092ebd9b-77a0-4877-afc3-dd8211730f71	2024-11-06	Warnings, Adverse reactions	Exact identifier application number: ANDA091404 rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
MEROPENEM	MEROPENEM	Xellia Pharmaceuticals USA LLC	06d84c55-94ff-46e5-8477-b8881c12eb0a	2024-07-10	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	ARMAS PHARMACEUTICALS INC	e1122310-c3ed-42f1-b189-301c221ff1f0	2022-07-29	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	WG Critical Care, LLC	6520ae3d-e149-499c-8152-36f6ab861662	2021-06-30	Warnings, Adverse reactions	Exact identifier rxcui: 1722934 rxcui: 1722939 unii: FV9J3JU8B1
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	12714f80-d6e5-4453-b66c-62f57c16ddfc	2021-03-12	Warnings, Adverse reactions	Exact identifier application number: ANDA091404 ndc (package): 63323-508-31 ndc (package): 63323-507-21 ndc (package): 63323-508-21 ndc (package): 63323-507-19 ndc (product): 63323-508 ndc (product): 63323-507 rxcui: 1722934 rxcui: 1722939 spl id: 6e7f961a-7766-4426-8aa4-096bfba99e56 spl set id: 12714f80-d6e5-4453-b66c-62f57c16ddfc unii: FV9J3JU8B1
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	7a68d899-2678-43a9-a9c1-ef8f916b562f	2021-03-10	Warnings, Adverse reactions	Exact identifier application number: ANDA091404 ndc (package): 63323-508-25 ndc (package): 63323-507-43 ndc (package): 63323-508-45 ndc (package): 63323-507-25 ndc (product): 63323-508 ndc (product): 63323-507 ndc11 (package): 63323050743 rxcui: 1722934 rxcui: 1722939 spl id: 8fe3d813-4656-49d6-ad91-6a075f3d3a82 spl set id: 7a68d899-2678-43a9-a9c1-ef8f916b562f unii: FV9J3JU8B1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.