FDA.reportPublic FDA data

GamaSTAN

Product NDC
13533-335
11-digit product format
135330335
Labeler code
13533
Product ID
13533-335_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
2018-02-05
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
13533-335-04GamaSTAN1 in 1 CARTONINJECTION, SOLUTION136
13533-335-12GamaSTAN1 in 1 CARTONINJECTION, SOLUTION136
13533-335-13GamaSTAN10 mL in 1 VIALINJECTION, SOLUTION1036
13533-335-40GamaSTAN2 mL in 1 VIALINJECTION, SOLUTION236

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-335-04ML - Milliliter13533-335c061f856-c204-460a-acae-446cfeef630312018-08-13
13533-335-12ML - Milliliter13533-335827c4fa2-d6e3-4816-9ecd-11454873429012018-08-13
13533-335-13ML - Milliliter13533-3350833b051-67e8-49e7-a434-851c6af0a65212018-08-13
13533-335-40ML - Milliliter13533-335a0bf277b-7ff6-4fd0-8b8b-d4ead94aa6d112018-08-13

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
13533-335GAMASTAN (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
13533-335-04135330335041 VIAL in 1 CARTON (13533-335-04) / 2 mL in 1 VIAL (13533-335-40) 1 vial2018-02-050000-00-00NoNoCurrent
13533-335-12135330335121 VIAL in 1 CARTON (13533-335-12) / 10 mL in 1 VIAL (13533-335-13) 1 vial2018-02-050000-00-00NoNoCurrent
13533-335-131353303351310 mL in 1 VIAL10 mlHistorical
13533-335-40135330335402 mL in 1 VIAL2 mlHistorical