FDA.reportPublic FDA data

Alyglo

Product NDC
61476-104
11-digit product format
614760104
Labeler code
61476
Product ID
61476-104_5d39e5bd-c8a4-4dab-a3c3-ca13ac44b3b0
Type
PLASMA DERIVATIVE
Nonproprietary name
Human immunoglobulin G
Dosage form
LIQUID
Route
INTRAVENOUS
Labeler
GC Biopharma Corp.
Application
BLA125743
Marketing category
BLA
Marketing start
2023-12-15
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
100 mg/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
Alyglo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G100 mg/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
61476-104-01Alyglo50 mL in 1 VIAL, GLASSLIQUID504
61476-104-02Alyglo100 mL in 1 VIAL, GLASSLIQUID1004
61476-104-03Alyglo200 mL in 1 VIAL, GLASSLIQUID2004
61476-104-05Alyglo1 in 1 CARTONLIQUID14
61476-104-10Alyglo1 in 1 CARTONLIQUID14
61476-104-20Alyglo1 in 1 CARTONLIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61476-104-01ML - Milliliter61476-10423eb1bb3-ba83-4997-bc28-eb11604c368312024-04-05
61476-104-02ML - Milliliter61476-104761481f0-6084-4b76-8300-32602bb55b6f12024-04-05
61476-104-03ML - Milliliter61476-10457f9a0df-458b-42a4-9fad-8b963c8d315f12024-04-05
61476-104-05ML - Milliliter61476-1046bbe6ed0-05c6-4064-b6fb-74d14d1507d712024-04-05
61476-104-10ML - Milliliter61476-104fe32b17f-e058-4e3a-a1cf-8463ce9e971412024-04-05
61476-104-20ML - Milliliter61476-104c93928b0-eeca-4c27-8688-71bfdcbb64d912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61476-104ALYGLO (HUMAN IMMUNOGLOBULIN G) LIQUID [GC BIOPHARMA CORP.]1Current NDC, 6 package rows20231228_fb97b3ec-29ee-4df1-aa99-c23e57a21228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672108Alyglo 10 % in 100 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672110Alyglo 10 % in 200 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672105Alyglo 10 % in 50 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672107immune globulin intravenous (human) - stwk 10 % in 100 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672109immune globulin intravenous (human) - stwk 10 % in 200 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672098immune globulin intravenous (human) - stwk 10 % in 50 ML InjectionPSNfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672108100 ML immune globulin intravenous (human) - stwk 100 MG/ML Injection [Alyglo]SBDfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672110200 ML immune globulin intravenous (human) - stwk 100 MG/ML Injection [Alyglo]SBDfb97b3ec-29ee-4df1-aa99-c23e57a212284
267210550 ML immune globulin intravenous (human) - stwk 100 MG/ML Injection [Alyglo]SBDfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672107100 ML immune globulin intravenous (human) - stwk 100 MG/ML InjectionSCDfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672109200 ML immune globulin intravenous (human) - stwk 100 MG/ML InjectionSCDfb97b3ec-29ee-4df1-aa99-c23e57a212284
267209850 ML immune globulin intravenous (human) - stwk 100 MG/ML InjectionSCDfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672108Alyglo 10 % per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672110Alyglo 10 % per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672105Alyglo 10 % per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672108Alyglo 10 GM per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672108Alyglo 100 MG/ML per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672110Alyglo 100 MG/ML per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672105Alyglo 100 MG/ML per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672110Alyglo 20 GM per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672105Alyglo 5 GM per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672107immune globulin intravenous (human) - stwk 10 % per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672109immune globulin intravenous (human) - stwk 10 % per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672098immune globulin intravenous (human) - stwk 10 % per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672107immune globulin intravenous (human) - stwk 10 GM per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672107immune globulin intravenous (human) - stwk 100 MG/ML per 100 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672109immune globulin intravenous (human) - stwk 100 MG/ML per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672098immune globulin intravenous (human) - stwk 100 MG/ML per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672109immune globulin intravenous (human) - stwk 20 GM per 200 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284
2672098immune globulin intravenous (human) - stwk 5 GM per 50 ML InjectionSYfb97b3ec-29ee-4df1-aa99-c23e57a212284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61476-104-016147601040150 mL in 1 VIAL, GLASS50 mlHistorical
61476-104-0261476010402100 mL in 1 VIAL, GLASS100 mlHistorical
61476-104-0361476010403200 mL in 1 VIAL, GLASS200 mlHistorical
61476-104-05614760104051 VIAL, GLASS in 1 CARTON (61476-104-05) / 50 mL in 1 VIAL, GLASS (61476-104-01) 2023-12-15NoNoCurrent
61476-104-10614760104101 VIAL, GLASS in 1 CARTON (61476-104-10) / 100 mL in 1 VIAL, GLASS (61476-104-02) 2023-12-15NoNoCurrent
61476-104-20614760104201 VIAL, GLASS in 1 CARTON (61476-104-20) / 200 mL in 1 VIAL, GLASS (61476-104-03) 2023-12-15NoNoCurrent