FDA.reportPublic FDA data

Panzyga

Product NDC
0069-1312
11-digit product format
000691312
Labeler code
0069
Product ID
0069-1312_fb008bad-3696-e7b9-d3f8-3718e16e19d8
Type
PLASMA DERIVATIVE
Nonproprietary name
immune globulin intravenous (human)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA125587
Marketing category
BLA
Marketing start
2019-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G100 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1312-01Panzyga100 mL in 1 BOTTLE, GLASSSOLUTION10010
0069-1312-02Panzyga1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1312-01ML - Milliliter0069-1312189a061f-b883-4fe8-bfeb-fa08197b2c2312019-09-05
0069-1312-02ML - Milliliter0069-1312b035f75d-31c2-4959-874c-11e4a73fd78112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1312PANZYGA (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]9Current NDC, Legacy NDC, 2 package rows20250410_e2cc5ddf-119e-ade3-79c2-c712cfbee099.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102435immune globulin intravenous (human) - ifas 10 % in 10 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102463immune globulin intravenous (human) - ifas 10 % in 100 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102469immune globulin intravenous (human) - ifas 10 % in 200 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102455immune globulin intravenous (human) - ifas 10 % in 25 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102471immune globulin intravenous (human) - ifas 10 % in 300 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102459immune globulin intravenous (human) - ifas 10 % in 50 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102440panzyga 10 % in 10 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102464panzyga 10 % in 100 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102470panzyga 10 % in 200 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102456panzyga 10 % in 25 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102472panzyga 10 % in 300 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102460panzyga 10 % in 50 ML InjectionPSNe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210244010 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102464100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102470200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210245625 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102472300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210246050 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210243510 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102463100 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102469200 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210245525 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102471300 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210245950 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCDe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210244010 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102464100 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102470200 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210245625 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102472300 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
210246050 ML Panzyga 100 MG/ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102435immune globulin intravenous (human) - ifas 10 % per 10 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102463immune globulin intravenous (human) - ifas 10 % per 100 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102469immune globulin intravenous (human) - ifas 10 % per 200 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102455immune globulin intravenous (human) - ifas 10 % per 25 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102471immune globulin intravenous (human) - ifas 10 % per 300 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102459immune globulin intravenous (human) - ifas 10 % per 50 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102440Panzyga 10 % per 10 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102464Panzyga 10 % per 100 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102470Panzyga 10 % per 200 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102456Panzyga 10 % per 25 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102472Panzyga 10 % per 300 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910
2102460Panzyga 10 % per 50 ML InjectionSYe2cc5ddf-119e-ade3-79c2-c712cfbee09910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-1312-0100069131201100 mL in 1 BOTTLE, GLASS100 mlHistorical
0069-1312-02000691312021 BOTTLE, GLASS in 1 CARTON (0069-1312-02) / 100 mL in 1 BOTTLE, GLASS (0069-1312-01) 2019-08-090000-00-00NoNoCurrent