NDC 65293-009-01 - VABOMERE

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: 65293-009
Requested NDC: 65293-009-01
Package NDCs from labels: 65293-009-01, 65293-009-06
Manufacturer: The Medicines Company | Facta Farmaceutici S.p.A.
Effective date: 2017-08-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
VABOMERE - The Medicines Company \| Facta Farmaceutici S.p.A.	The Medicines Company \| Facta Farmaceutici S.p.A.	2017-08-29	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65293-009-06	2020-02-12	C162847	48780-1	9d75b9cf-dcfa-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VABOMERE safely and effectively. See full prescribing information forVABOMERE. VABOMERE™ (meropenem and vaborbactam) for injection, for intravenous use Initial U.S. Approval: 2017
65293-009-06	2020-01-31	C162847	48780-1	9d75b9cf-dcfa-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use VABOMERE safely and effectively. See full prescribing information forVABOMERE. VABOMERE™ (meropenem and vaborbactam) for injection, for intravenous use Initial U.S. Approval: 2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65293-009-01	EA - Each	65293-009	8cdae45a-db8d-4286-80fa-9ed1060b8746	1	2017-10-13
65293-009-06	EA - Each	65293-009	cb143b36-93c9-43ab-ba11-ae1cef62799c	1	2017-10-13

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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Distress-Mood-Sadness	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	98d08917-2f1b-4dc7-e053-2a95a90a1ce0	2020-12-02	Warnings	Exact identifier unii: 45P3261C7T
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	79890e75-dfac-0262-e053-2a91aa0a5ce5	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	798ab5a2-7464-8e9d-e053-2a91aa0acc98	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Cold Hands - Feet	HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA	Newton Laboratories, Inc.	7a2b4f28-2128-a8b2-e053-2a91aa0a2402	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Meropenem	MEROPENEM	Fresenius Kabi USA, LLC	185181e3-c004-4d61-b992-5df94fe57a90	2020-10-19	Warnings, Adverse reactions	Exact identifier unii: FV9J3JU8B1
580db23f-c656-3049-e053-2a91aa0ad616			580db23f-c655-3049-e053-2a91aa0ad616	2017-08-29	Warnings, Adverse reactions	Exact identifier spl id: 580db23f-c656-3049-e053-2a91aa0ad616 spl set id: 580db23f-c655-3049-e053-2a91aa0ad616

Reported adverse events (FAERS/openFDA)#

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