NDC 0781-3265-80 - 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: 0781-3265
Requested NDC: 0781-3265-80
Package NDCs from labels: 0781-3265-80, 0781-3265-95
Manufacturer: Sandoz Inc
Effective date: 2013-04-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Meropenem - Sandoz Inc	Sandoz Inc	2013-04-02	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-3265-95	2021-01-07	C162847	48780-1	9d75b9d0-ee7b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for Injection Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible b
0781-3265-95	2020-01-31	C162847	48780-1	9d75b9d0-ee7b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for Injection Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3265-80	EA - Each	0781-3265	51a28181-18a5-4265-9897-3adb3ccfb3b2	1	2012-07-24
0781-3265-95	EA - Each	0781-3265	bc31f5e0-240f-44df-8075-440b3e5aba9d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEROPENEM	ACTIVE INGREDIENT	FV9J3JU8B1	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17
MEROPENEM ANHYDROUS	ACTIVE MOIETY	YOP6PX0BAO	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	MEROPENEM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]	17

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
5de5ec96-2d2d-44c6-addf-1bc8034881c0			a0fcc561-9566-4223-84b3-baa5cf3e0a20	2014-05-28	Warnings, Adverse reactions	Exact identifier spl set id: a0fcc561-9566-4223-84b3-baa5cf3e0a20

Reported adverse events (FAERS/openFDA)#

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