FDA.reportPublic FDA data

NDC 13533-810-06 - XEMBIFY

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
13533-810
Requested NDC
13533-810-06
Package NDCs from labels
13533-810-06, 13533-810-05, 13533-810-11, 13533-810-10, 13533-810-21, 13533-810-20, 13533-810-51, 13533-810-50
Manufacturer
GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC
Effective date
2025-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XEMBIFY - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLCGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC2025-03-17PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-810-05XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-06XEMBIFY5 mL in 1 VIALSOLUTION512
13533-810-10XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-11XEMBIFY10 mL in 1 VIALSOLUTION1012
13533-810-20XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-21XEMBIFY20 mL in 1 VIALSOLUTION2012
13533-810-50XEMBIFY1 in 1 CARTONSOLUTION112
13533-810-51XEMBIFY50 mL in 1 VIALSOLUTION5012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-810XEMBIFY (IMMUNE GLOBULIN SUBCUTANEOUS, HUMAN-KLHW) SOLUTION [GRIFOLS USA, LLC]12Current NDC, Legacy NDC, 8 package rows20250322_8c174b11-a061-412e-a3b2-7bf7e1adaace.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-810-05ML - Milliliter13533-810642633fd-947b-48a2-af62-2e8e27fee45f12019-10-07
13533-810-06ML - Milliliter13533-8105f65762a-8e40-4875-9352-7d3094820ce712019-10-07
13533-810-10ML - Milliliter13533-8101d855bc1-cd67-4608-aa8a-94d2ab6052d312019-10-07
13533-810-11ML - Milliliter13533-810914b1894-2e6a-463c-873e-b07eb29c507d12019-10-07
13533-810-20ML - Milliliter13533-810612e51aa-9f8d-40a2-b76a-f16bc1306b1612019-10-07
13533-810-21ML - Milliliter13533-810537ae1ac-46df-4e8a-bbee-75ee9ffac42812019-10-07
13533-810-50ML - Milliliter13533-810426532a9-9b8a-477b-9de1-5cad108b412b12019-10-07
13533-810-51ML - Milliliter13533-810f41299a4-d44f-48f1-96f2-b2cb65899f1012019-10-07

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 9 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
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: TE7660XO1C
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: TE7660XO1C
GlycineGLYCINEB. Braun Medical Inc.f4d83550-42de-44c7-b8d5-1d0debc6aec22021-04-01Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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