FDA.reportPublic FDA data

NDC 68547-578-01 - ZEVTERA

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
68547-578
Requested NDC
68547-578-01
Package NDCs from labels
68547-578-01, 68547-578-10
Manufacturer
La Jolla Pharmaceutical Company | ISTx, LLC
Effective date
2026-09-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZEVTERA - La Jolla Pharmaceutical Company | ISTx, LLCLa Jolla Pharmaceutical Company | ISTx, LLC2026-09-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68547-578-01ZEVTERA1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION14
68547-578-10ZEVTERA10 in 1 BOXINJECTION, POWDER, FOR SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68547-578ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) INJECTION, POWDER, FOR SOLUTION [LA JOLLA PHARMACEUTICAL COMPANY]3Current NDC, 2 package rows20250416_2bd685df-7dc6-78a6-e063-6294a90a580b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68547-578-01EA - Each68547-57856e96ee0-85f6-4054-b615-6a073e85a13012025-05-14
68547-578-10EA - Each68547-578be3889ba-80ca-4035-ac67-16dde11a4bcc12025-05-14

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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 2968PHW8QP
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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