Gamunex-C

Product NDC
13533-805
11-digit product format
135330805
Labeler code
13533
Product ID
13533-805_2c4ac1fc-ff0d-408c-95a7-dd90712d71bb
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin (Human)
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA125046
Marketing category
BLA
Marketing start
2010-10-13
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
10 g/100mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gamunex-C
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G10 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-805-00Gamunex-C50 mL in 1 BAGINJECTION503
13533-805-01Gamunex-C1 in 1 CARTONINJECTION13
13533-805-10Gamunex-C100 mL in 1 BAGINJECTION1003
13533-805-11Gamunex-C1 in 1 CARTONINJECTION13
13533-805-30Gamunex-C200 mL in 1 BAGINJECTION2003
13533-805-31Gamunex-C1 in 1 CARTONINJECTION13
13533-805-44Gamunex-C400 mL in 1 BAGINJECTION4003
13533-805-45Gamunex-C1 in 1 CARTONINJECTION13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809582gamunex-C 10 % in 100 mL InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809583gamunex-C 10 % in 200 mL InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809584gamunex-C 10 % in 400 mL InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809578gamunex-C 10 % in 50 mL InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809524immunoglobulin G, human 10 % in 400 ML InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSN4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809582100 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]SBD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809583200 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]SBD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809584400 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]SBD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
180957850 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]SBD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809524400 ML immunoglobulin G, human 100 MG/ML InjectionSCD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCD4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809582100 ML Gamunex 100 MG/ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809583200 ML Gamunex 100 MG/ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809584400 ML Gamunex 100 MG/ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
180957850 ML Gamunex 100 MG/ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809578Gamunex 10 % per 50 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809582Gamunex 10 GM per 100 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809583Gamunex 20 GM per 200 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809584Gamunex 40 GM per 400 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809582Gamunex-C 10 % per 100 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809583Gamunex-C 10 % per 200 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809584Gamunex-C 10 % per 400 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809578Gamunex-C 5 GM per 50 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809421immunoglobulin G, human 10 % per 100 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809444immunoglobulin G, human 10 % per 200 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809524immunoglobulin G, human 10 % per 400 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809414immunoglobulin G, human 10 % per 50 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809524immunoglobulin G, human 40 GM per 400 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSY4fe97dac-d952-40f5-9c6a-67cda048ad8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13533-805-001353308050050 mL in 1 BAG50 mlHistorical
13533-805-01135330805011 BAG in 1 CARTON (13533-805-01) / 50 mL in 1 BAG (13533-805-00) 1 bag2010-10-13NoNoHistorical
13533-805-1013533080510100 mL in 1 BAG100 mlHistorical
13533-805-11135330805111 BAG in 1 CARTON (13533-805-11) / 100 mL in 1 BAG (13533-805-10) 1 bag2010-10-13NoNoHistorical
13533-805-3013533080530200 mL in 1 BAG200 mlHistorical
13533-805-31135330805311 BAG in 1 CARTON (13533-805-31) / 200 mL in 1 BAG (13533-805-30) 1 bag2010-10-13NoNoHistorical
13533-805-4413533080544400 mL in 1 BAG400 mlHistorical
13533-805-45135330805451 BAG in 1 CARTON (13533-805-45) / 400 mL in 1 BAG (13533-805-44) 1 bag2010-10-13NoNoHistorical