FDA.reportPublic FDA data

GAMASTAN

Product NDC
13533-635
11-digit product format
135330635
Labeler code
13533
Product ID
13533-635_10baba80-5b1a-47f4-aedd-5f36a7d0c331
Type
PLASMA DERIVATIVE
Nonproprietary name
IMMUNE GLOBULIN (HUMAN)
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
GRIFOLS USA, LLC
Application
BLA101134
Marketing category
BLA
Marketing start
1996-08-14
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
.165 g/mL
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
GAMASTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G.165 g/mL

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
13533-635-04GAMASTAN1 in 1 CARTONINJECTION, SOLUTION136
13533-635-12GAMASTAN1 in 1 CARTONINJECTION, SOLUTION136
13533-635-13GAMASTAN10 mL in 1 VIALINJECTION, SOLUTION1036
13533-635-40GAMASTAN2 mL in 1 VIALINJECTION, SOLUTION236

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-635-02ML - Milliliter13533-635c102249c-5e88-45bd-9955-3285dffecfcf12014-10-03
13533-635-04ML - Milliliter13533-63581910d1d-daf2-4fb2-8c3b-e9015576fa0512012-07-24
13533-635-10ML - Milliliter13533-6356d0db6c9-d0d4-47e6-a866-83bd48b57c7a12014-10-03
13533-635-12ML - Milliliter13533-6354a314ce8-c6ee-42ad-a225-eb06e36bba1d12012-07-24
13533-635-13ML - Milliliter13533-635d4305d4b-4268-4253-b2f4-8a1c9918ff8212014-10-03
13533-635-40ML - Milliliter13533-63558035c66-6f1b-4db0-a2cc-a19d09b8417412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Immunoglobulin GACTIVE INGREDIENT66Y330CJHSGAMASTAN S/D (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]21
Human Immunoglobulin GACTIVE MOIETY66Y330CJHSGAMASTAN S/D (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]21
GlycineINACTIVE INGREDIENTTE7660XO1CGAMASTAN S/D (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-635GAMASTAN (IMMUNE GLOBULIN (HUMAN)) INJECTION, SOLUTION GAMASTAN (IMMUNE GLOBULIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]36Current NDC, Legacy NDC, 4 package rows20241004_561f48de-2697-4a35-8233-bd1cdb73438f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809038GamaSTAN 15-18 % in 10 ML InjectionPSN561f48de-2697-4a35-8233-bd1cdb73438f36
1809034GamaSTAN 15-18 % in 2 ML InjectionPSN561f48de-2697-4a35-8233-bd1cdb73438f36
1809037immunoglobulin G, human 15-18 % in 10 ML InjectionPSN561f48de-2697-4a35-8233-bd1cdb73438f36
1809032immunoglobulin G, human 15-18 % in 2 ML InjectionPSN561f48de-2697-4a35-8233-bd1cdb73438f36
180903810 ML immunoglobulin G, human 180 MG/ML Injection [GamaSTAN]SBD561f48de-2697-4a35-8233-bd1cdb73438f36
18090342 ML immunoglobulin G, human 180 MG/ML Injection [GamaSTAN]SBD561f48de-2697-4a35-8233-bd1cdb73438f36
180903710 ML immunoglobulin G, human 180 MG/ML InjectionSCD561f48de-2697-4a35-8233-bd1cdb73438f36
18090322 ML immunoglobulin G, human 180 MG/ML InjectionSCD561f48de-2697-4a35-8233-bd1cdb73438f36
180903810 ML GamaSTAN 180 MG/ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36
18090342 ML GamaSTAN 180 MG/ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36
1809038GamaSTAN 15-18 % per 10 ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36
1809034GamaSTAN 15-18 % per 2 ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36
1809037immunoglobulin G, human 15-18 % per 10 ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36
1809032immunoglobulin G, human 15-18 % per 2 ML InjectionSY561f48de-2697-4a35-8233-bd1cdb73438f36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-635-04135330635041 VIAL in 1 CARTON (13533-635-04) / 2 mL in 1 VIAL (13533-635-40) 1 vial1996-08-140000-00-00NoNoCurrent
13533-635-12135330635121 VIAL in 1 CARTON (13533-635-12) / 10 mL in 1 VIAL (13533-635-13) 1 vial1996-08-140000-00-00NoNoCurrent
13533-635-131353306351310 mL in 1 VIAL10 mlHistorical
13533-635-40135330635402 mL in 1 VIAL2 mlHistorical