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 10 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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: TE7660XO1C
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
GlycineGLYCINEBaxter Healthcare Corporationd4665408-04d8-4ad7-8589-708d4defb8692018-01-02Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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