FDA.reportPublic FDA data

NDC 44206-455-93 - Hizentra

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
44206-455
Requested NDC
44206-455-93
Package NDCs from labels
44206-455-93, 44206-455-10, 44206-455-97, 44206-455-25
Manufacturer
CSL Behring AG
Effective date
2023-04-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hizentra - CSL Behring AGCSL Behring AG2023-04-20PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44206-455-10Hizentra1 in 1 CARTONLIQUID126
44206-455-25Hizentra1 in 1 CARTONLIQUID126
44206-455-93Hizentra50 mL in 1 VIAL, SINGLE-DOSELIQUID5026
44206-455-97Hizentra50 mL in 1 SYRINGELIQUID5026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44206-455HIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]26Current NDC, Legacy NDC, 4 package rows20230429_7b58f5ff-0316-49a3-b585-1f6003ddb953.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44206-455-10ML - Milliliter44206-4558718d6e7-ccf6-4b3e-99fa-d9a192a3ab5812013-11-04
44206-455-25ML - Milliliter44206-4556b22b3ab-353a-483f-ab98-5a949383030d12023-12-05
44206-455-93ML - Milliliter44206-4553de3cbd6-3fa3-4e16-9a72-036aa8752aa112017-03-06
44206-455-97ML - Milliliter44206-455efadd6d7-88ef-45c7-a161-7ac3f273a8b612024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
Human immunoglobulin GACTIVE MOIETY66Y330CJHSHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
HUMAN IMMUNOGLOBULIN AINACTIVE INGREDIENT741C1PWQ88HIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]13
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VHIZENTRA (HUMAN IMMUNOGLOBULIN G) LIQUID [CSL BEHRING AG]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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: 9DLQ4CIU6V
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 9DLQ4CIU6V
CLINIMIXLEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSEBaxter Healthcare Corporationdccff103-8695-400c-a15d-cc2fd078760a2021-04-13Warnings, Adverse reactionsExact identifier
unii: 9DLQ4CIU6V
TravasolLEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINEBaxter Healthcare Corporation8543b5be-0f43-4891-9e56-d7c39fe839b52020-10-07Warnings, Adverse reactionsExact identifier
unii: 9DLQ4CIU6V
312499ac-9875-4004-b558-321a33399afd7b58f5ff-0316-49a3-b585-1f6003ddb9532011-02-28Warnings, Adverse reactionsExact identifier
spl set id: 7b58f5ff-0316-49a3-b585-1f6003ddb953

Reported adverse events (FAERS/openFDA)#

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