NDC 13533-800-41 - Gamunex-C

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
13533-800
Requested NDC
13533-800-41
Package NDCs from labels
13533-800-13, 13533-800-12, 13533-800-16, 13533-800-15, 13533-800-21, 13533-800-20, 13533-800-72, 13533-800-71, 13533-800-25, 13533-800-24, 13533-800-41, 13533-800-40
Manufacturer
GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLC
Effective date
2022-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLCGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | GRIFOLS BIOLOGICALS LLC2022-04-29PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-800-12Gamunex-C1 in 1 CARTONINJECTION137
13533-800-13Gamunex-C10 mL in 1 VIAL, GLASSINJECTION1037
13533-800-15Gamunex-C1 in 1 CARTONINJECTION137
13533-800-16Gamunex-C25 mL in 1 VIAL, GLASSINJECTION2537
13533-800-20Gamunex-C1 in 1 CARTONINJECTION137
13533-800-21Gamunex-C50 mL in 1 VIAL, GLASSINJECTION5037
13533-800-24Gamunex-C1 in 1 CARTONINJECTION137
13533-800-25Gamunex-C200 mL in 1 VIAL, GLASSINJECTION20037
13533-800-40Gamunex-C1 in 1 CARTONINJECTION137
13533-800-41Gamunex-C400 mL in 1 VIAL, GLASSINJECTION40037
13533-800-71Gamunex-C1 in 1 CARTONINJECTION137
13533-800-72Gamunex-C100 mL in 1 VIAL, GLASSINJECTION10037

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-800GAMUNEX-C (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]37Current NDC, Legacy NDC, 12 package rows20220503_ade6b84a-e95b-0a49-3296-f56208fdf35b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-800-12ML - Milliliter13533-800df75549e-d5ff-4225-8b52-d51725b3302212012-07-24
13533-800-13ML - Milliliter13533-800b1372be0-70fe-4954-9871-4095466410c112014-01-04
13533-800-15ML - Milliliter13533-800471c16ba-d38d-46c3-a135-7a8f407a0ded12012-07-24
13533-800-16ML - Milliliter13533-8008e0e046f-04a8-463e-b5bb-7bd4a1931c6e12014-01-04
13533-800-20ML - Milliliter13533-800cda8f47f-9295-49eb-811c-be05a22f635f12012-07-24
13533-800-21ML - Milliliter13533-8002b16c85b-1ab4-4ed4-84e1-2e7e3775955e12014-01-04
13533-800-24ML - Milliliter13533-800562b26f3-16fc-45b0-8c57-6f9eef215ad212012-07-24
13533-800-25ML - Milliliter13533-800e2fb868d-7ed9-4abe-b4d9-9a0d08cac7a312013-08-02
13533-800-40ML - Milliliter13533-80084a95c19-eb93-4fe4-a9f3-404c2e76beaa12014-11-05
13533-800-41ML - Milliliter13533-800bf43376d-03d9-4e35-930b-ce084d45e47912014-11-05
13533-800-71ML - Milliliter13533-800923e33f6-1219-411d-a0b3-a772f08e1e7c12012-07-24
13533-800-72ML - Milliliter13533-800be54eece-9bbc-4985-9eff-eb0b6fa40b0012013-08-02

DailyMed Socrata Ingredients#

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 4 of 10 · 181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycineGLYCINEICU Medical Inc.c10a4657-cf64-4a71-a247-363dd58993bc2025-10-21Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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