FDA.reportPublic FDA data

Gammaplex

Product NDC
64208-8235
11-digit product format
642088235
Labeler code
64208
Product ID
64208-8235_a1aa7eb5-47eb-4da5-b8ad-d32b52594a2e
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN IMMUNOGLOBULIN G
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Bio Products Laboratory Ltd
Application
BLA125329
Marketing category
BLA
Marketing start
2017-04-07
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
5 g/50mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gammaplex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G5 g/50mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64208-8235-1Gammaplex50 mL in 1 BOTTLE, GLASSSOLUTION5016
64208-8235-2Gammaplex100 mL in 1 BOTTLE, GLASSSOLUTION10016
64208-8235-3Gammaplex200 mL in 1 BOTTLE, GLASSSOLUTION20016
64208-8235-5Gammaplex1 in 1 CARTONSOLUTION116
64208-8235-6Gammaplex1 in 1 CARTONSOLUTION116
64208-8235-7Gammaplex1 in 1 CARTONSOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64208-8235-1ML - Milliliter64208-823568f01dc7-a715-48e2-abf5-c42c849d38d812017-04-05
64208-8235-2ML - Milliliter64208-8235d2bbb8d0-5ce4-4c45-8987-ab4a3bac0bb712017-04-05
64208-8235-3ML - Milliliter64208-823584f2aac4-b410-4c9b-90d3-9ac5922f2e0612017-04-05
64208-8235-5ML - Milliliter64208-823555655279-1449-476e-a5f6-d2c7f54316d212017-04-05
64208-8235-6ML - Milliliter64208-823588c48641-b3fa-4637-8f83-7e96f4177e3412017-04-05
64208-8235-7ML - Milliliter64208-823501edafc8-a853-4613-ab1b-b2910599335412017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64208-8235GAMMAPLEX (HUMAN IMMUNOGLOBULIN G) SOLUTION [BIO PRODUCTS LABORATORY LIMITED]14Current NDC, Legacy NDC, 6 package rows20241009_2098af41-aec7-4af7-98bb-54f8ab55f30e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1876673Gammaplex 10 % in 100 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876674Gammaplex 10 % in 200 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876671Gammaplex 10 % in 50 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSN2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876673100 ML immunoglobulin G, human 100 MG/ML Injection [Gammaplex]SBD2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876674200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaplex]SBD2098af41-aec7-4af7-98bb-54f8ab55f30e16
187667150 ML immunoglobulin G, human 100 MG/ML Injection [Gammaplex]SBD2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCD2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCD2098af41-aec7-4af7-98bb-54f8ab55f30e16
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCD2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876673100 ML Gammaplex 100 MG/ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876674200 ML Gammaplex 100 MG/ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
187667150 ML Gammaplex 100 MG/ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876673Gammaplex 10 % per 100 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876674Gammaplex 10 % per 200 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1876671Gammaplex 10 % per 50 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809421immunoglobulin G, human 10 % per 100 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809444immunoglobulin G, human 10 % per 200 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809414immunoglobulin G, human 10 % per 50 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSY2098af41-aec7-4af7-98bb-54f8ab55f30e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64208-8235-16420882350150 mL in 1 BOTTLE, GLASS50 mlHistorical
64208-8235-264208823502100 mL in 1 BOTTLE, GLASS100 mlHistorical
64208-8235-364208823503200 mL in 1 BOTTLE, GLASS200 mlHistorical
64208-8235-5642088235051 BOTTLE, GLASS in 1 CARTON (64208-8235-5) / 50 mL in 1 BOTTLE, GLASS (64208-8235-1) 2017-04-070000-00-00NoNoCurrent
64208-8235-6642088235061 BOTTLE, GLASS in 1 CARTON (64208-8235-6) / 100 mL in 1 BOTTLE, GLASS (64208-8235-2) 2017-04-070000-00-00NoNoCurrent
64208-8235-7642088235071 BOTTLE, GLASS in 1 CARTON (64208-8235-7) / 200 mL in 1 BOTTLE, GLASS (64208-8235-3) 2017-04-070000-00-00NoNoCurrent