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 2 of 10 · 181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
AKSO N2 Youth Complex EssenceARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, DIOSCOREA VILLOSA, TYROSINEHEALWAY5028304b-22b4-c191-e063-6394a90a55252026-04-23WarningsExact identifier
unii: TE7660XO1C
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
QIVIGY kthmHUMAN IMMUNOGLOBULIN GKedrion S.p.A.6f1933e0-240f-48f4-b246-8a30e63a41602026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 66Y330CJHS
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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