FDA.reportPublic FDA data

NDC 64208-8234-1 - Gammaplex

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
64208-8234
Requested NDC
64208-8234-1
Package NDCs from labels
64208-8234-2, 64208-8234-6, 64208-8234-3, 64208-8234-7, 64208-8234-4, 64208-8234-8, 64208-8234-1
Manufacturer
Bio Products Laboratory Limited
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gammaplex - Bio Products Laboratory LimitedBio Products Laboratory Limited2025-09-16PLASMA DERIVATIVE
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64208-8234-2Gammaplex100 mL in 1 BOTTLE, GLASSSOLUTION10026
64208-8234-3Gammaplex200 mL in 1 BOTTLE, GLASSSOLUTION20026
64208-8234-4Gammaplex400 mL in 1 BOTTLE, GLASSSOLUTION40026
64208-8234-6Gammaplex1 in 1 CARTONSOLUTION126
64208-8234-7Gammaplex1 in 1 CARTONSOLUTION126
64208-8234-8Gammaplex1 in 1 CARTONSOLUTION126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64208-8234GAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]25Current NDC, Legacy NDC, 6 package rows20241004_6c3ce068-59f0-413b-9f93-85fb597d55e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64208-8234-1ML - Milliliter64208-8234dcf50359-b5a7-4012-ba5e-39d3cbb90b9112012-07-24
64208-8234-2ML - Milliliter64208-82348c609e32-2def-4eef-816a-99974b24371412012-07-24
64208-8234-3ML - Milliliter64208-8234cb281e22-14fe-434b-bb6f-0bb10c1c608c12012-07-24
64208-8234-4ML - Milliliter64208-8234c2db06b2-80c7-4420-9938-4e3d7d92f1d012014-07-02
64208-8234-5ML - Milliliter64208-8234bc90da04-31fc-4606-a967-e4eed69b7b3512013-10-17
64208-8234-6ML - Milliliter64208-82342aab6285-0c3f-41f2-9f21-2630927cb38512013-10-17
64208-8234-7ML - Milliliter64208-8234f0b5484b-bbc2-46e4-9f0b-5aec9ca2767112013-10-17
64208-8234-8ML - Milliliter64208-8234e080b288-8cbd-433d-a375-7be4194a09cb12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
GLYCINEINACTIVE INGREDIENTTE7660XO1CGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12
SORBITOLINACTIVE INGREDIENT506T60A25RGAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]12

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 1 of 45 · 900 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C

Reported adverse events (FAERS/openFDA)#

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