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 3 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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