FDA.reportPublic FDA data

NDC 13533-692-72 - Plasbumin

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
13533-692
Requested NDC
13533-692-72
Package NDCs from labels
13533-692-17, 13533-692-16, 13533-692-21, 13533-692-20, 13533-692-72, 13533-692-71
Manufacturer
GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC
Effective date
2022-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Plasbumin - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLCGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC2022-11-18PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-692-16Plasbumin1 in 1 CARTONSOLUTION116
13533-692-17Plasbumin20 mL in 1 VIALSOLUTION2016
13533-692-20Plasbumin1 in 1 CARTONSOLUTION116
13533-692-21Plasbumin50 mL in 1 VIALSOLUTION5016
13533-692-71Plasbumin1 in 1 CARTONSOLUTION116
13533-692-72Plasbumin100 mL in 1 VIALSOLUTION10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-692PLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]16Current NDC, Legacy NDC, 6 package rows20221206_2eeb6b69-2013-c0a2-5e2f-0365114d41b4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-692-16ML - Milliliter13533-692879169b7-b15a-4b85-9f43-309c9b3d4fd212012-07-24
13533-692-17ML - Milliliter13533-692abb8f58f-0947-4d56-8b36-e0fb2291fe3812013-11-04
13533-692-20ML - Milliliter13533-692f5ecfe01-ff31-4168-9b40-f3eec4f7aed212012-07-24
13533-692-21ML - Milliliter13533-692d1a2e8d6-d370-482b-862b-656bc8be163012013-11-04
13533-692-71ML - Milliliter13533-69254592db4-e02f-4770-b56c-b4cf82909ec512012-07-24
13533-692-72ML - Milliliter13533-692fa2203d9-85d1-44c3-b26b-d931417bde7112013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (human)ACTIVE INGREDIENTZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]8
Albumin (human)ACTIVE MOIETYZIF514RVZRPLASBUMIN (ALBUMIN (HUMAN)) SOLUTION [GRIFOLS USA, LLC]8

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
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
fd5f30bb-f579-cff3-2153-c19377e859d92eeb6b69-2013-c0a2-5e2f-0365114d41b42010-04-30Warnings, Adverse reactionsExact identifier
spl set id: 2eeb6b69-2013-c0a2-5e2f-0365114d41b4

Reported adverse events (FAERS/openFDA)#

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