FDA.reportPublic FDA data

Gammaplex

Product NDC
64208-8234
11-digit product format
642088234
Labeler code
64208
Product ID
64208-8234_1d04657c-09be-4561-b0d0-1c02cb3f82c2
Type
PLASMA DERIVATIVE
Nonproprietary name
HUMAN IMMUNOGLOBULIN G
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Bio Products Laboratory Limited
Application
BLA125329
Marketing category
BLA
Marketing start
2010-11-01
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
5 g/100mL
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/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809511Gammaplex 5 % in 100 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809513Gammaplex 5 % in 200 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809514Gammaplex 5 % in 400 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809456immunoglobulin G, human 5 % in 100 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809463immunoglobulin G, human 5 % in 200 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809474immunoglobulin G, human 5 % in 400 ML InjectionPSN6c3ce068-59f0-413b-9f93-85fb597d55e526
1809511100 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]SBD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809513200 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]SBD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809514400 ML immunoglobulin G, human 50 MG/ML Injection [Gammaplex]SBD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809456100 ML immunoglobulin G, human 50 MG/ML InjectionSCD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809463200 ML immunoglobulin G, human 50 MG/ML InjectionSCD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809474400 ML immunoglobulin G, human 50 MG/ML InjectionSCD6c3ce068-59f0-413b-9f93-85fb597d55e526
1809511100 ML Gammaplex 50 MG/ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809513200 ML Gammaplex 50 MG/ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809514400 ML Gammaplex 50 MG/ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809513Gammaplex 10 GM per 200 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809514Gammaplex 20 GM per 400 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809511Gammaplex 5 % per 100 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809513Gammaplex 5 % per 200 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809514Gammaplex 5 % per 400 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809511Gammaplex 5 GM per 100 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809463immunoglobulin G, human 10 GM per 200 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809474immunoglobulin G, human 20 GM per 400 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809456immunoglobulin G, human 5 % per 100 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809463immunoglobulin G, human 5 % per 200 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809474immunoglobulin G, human 5 % per 400 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526
1809456immunoglobulin G, human 5 GM per 100 ML InjectionSY6c3ce068-59f0-413b-9f93-85fb597d55e526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64208-8234-264208823402100 mL in 1 BOTTLE, GLASS100 mlHistorical
64208-8234-364208823403200 mL in 1 BOTTLE, GLASS200 mlHistorical
64208-8234-464208823404400 mL in 1 BOTTLE, GLASS400 mlHistorical
64208-8234-5642088234051 BOTTLE, GLASS in 1 CARTON (64208-8234-5) > 50 mL in 1 BOTTLE, GLASS (64208-8234-1) 2010-11-010000-00-00NoNoCurrent
64208-8234-6642088234061 BOTTLE, GLASS in 1 CARTON (64208-8234-6) / 100 mL in 1 BOTTLE, GLASS (64208-8234-2) 2010-11-010000-00-00NoNoCurrent
64208-8234-7642088234071 BOTTLE, GLASS in 1 CARTON (64208-8234-7) / 200 mL in 1 BOTTLE, GLASS (64208-8234-3) 2010-11-010000-00-00NoNoCurrent
64208-8234-8642088234081 BOTTLE, GLASS in 1 CARTON (64208-8234-8) / 400 mL in 1 BOTTLE, GLASS (64208-8234-4) 2010-11-010000-00-00NoNoCurrent