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 3 of 10 · 181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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