FDA.reportPublic FDA data

Panzyga

Product NDC
68982-822
11-digit product format
689820822
Labeler code
68982
Product ID
68982-822_f5c107e3-09fc-5566-7f81-10904807e942
Type
PLASMA DERIVATIVE
Nonproprietary name
immune globulin intravenous (human)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125587
Marketing category
BLA
Marketing start
2018-11-12
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
68982-822-01Panzyga1 in 1 CARTONSOLUTION12
68982-822-02Panzyga1 in 1 CARTONSOLUTION12
68982-822-03Panzyga1 in 1 CARTONSOLUTION12
68982-822-04Panzyga1 in 1 CARTONSOLUTION12
68982-822-05Panzyga1 in 1 CARTONSOLUTION12
68982-822-06Panzyga1 in 1 CARTONSOLUTION12
68982-822-81Panzyga10 mL in 1 BOTTLE, GLASSSOLUTION102
68982-822-82Panzyga25 mL in 1 BOTTLE, GLASSSOLUTION252
68982-822-83Panzyga50 mL in 1 BOTTLE, GLASSSOLUTION502
68982-822-84Panzyga100 mL in 1 BOTTLE, GLASSSOLUTION1002
68982-822-85Panzyga200 mL in 1 BOTTLE, GLASSSOLUTION2002
68982-822-86Panzyga300 mL in 1 BOTTLE, GLASSSOLUTION3002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-822-01ML - Milliliter68982-8229deba982-3c31-4e37-909a-919eb0bad54412021-08-05
68982-822-02ML - Milliliter68982-8222b7623a5-ab51-4f38-b6f7-c6ccc558075c12021-08-05
68982-822-03ML - Milliliter68982-822f305ef61-a447-468c-8633-3e4b069c6dd612021-08-05
68982-822-04ML - Milliliter68982-82237fcd036-73f2-409c-9df1-54bfd8efadf012021-08-05
68982-822-05ML - Milliliter68982-8224f12c8d4-b911-4798-a99f-22d0fb4877ba12021-08-05
68982-822-06ML - Milliliter68982-82291c1f95b-bd80-45d0-9eb0-3f4aeb81257512021-08-05
68982-822-81ML - Milliliter68982-822b939dc4d-1726-402f-9712-2e60ed7118f112021-08-05
68982-822-82ML - Milliliter68982-822975de22e-100a-4814-a06c-f2542785c0e112021-08-05
68982-822-83ML - Milliliter68982-8223034fc6c-6ff7-4fca-9cb1-59626b45650912021-08-05
68982-822-85ML - Milliliter68982-822479739d5-da8f-4005-aea2-7520ef09324312021-08-05
68982-822-86ML - Milliliter68982-8225146171f-f812-47ca-9fdb-b0bb6348483912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-822PANZYGA (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) SOLUTION [OCTAPHARMA USA INC]1Current NDC, Legacy NDC, 12 package rows20210716_9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102435immune globulin intravenous (human) - ifas 10 % in 10 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102463immune globulin intravenous (human) - ifas 10 % in 100 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102469immune globulin intravenous (human) - ifas 10 % in 200 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102455immune globulin intravenous (human) - ifas 10 % in 25 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102471immune globulin intravenous (human) - ifas 10 % in 300 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102459immune globulin intravenous (human) - ifas 10 % in 50 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102440panzyga 10 % in 10 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102464panzyga 10 % in 100 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102470panzyga 10 % in 200 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102456panzyga 10 % in 25 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102472panzyga 10 % in 300 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102460panzyga 10 % in 50 ML InjectionPSN9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210244010 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102464100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102470200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210245625 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102472300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210246050 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210243510 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102463100 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102469200 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210245525 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102471300 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210245950 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210244010 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102464100 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102470200 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210245625 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102472300 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
210246050 ML Panzyga 100 MG/ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102435immune globulin intravenous (human) - ifas 10 % per 10 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102463immune globulin intravenous (human) - ifas 10 % per 100 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102469immune globulin intravenous (human) - ifas 10 % per 200 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102455immune globulin intravenous (human) - ifas 10 % per 25 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102471immune globulin intravenous (human) - ifas 10 % per 300 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102459immune globulin intravenous (human) - ifas 10 % per 50 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102440Panzyga 10 % per 10 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102464Panzyga 10 % per 100 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102470Panzyga 10 % per 200 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102456Panzyga 10 % per 25 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102472Panzyga 10 % per 300 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02
2102460Panzyga 10 % per 50 ML InjectionSY9306c5f7-ddf9-5190-d0c1-31ba9ca2d0e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-822-01689820822011 BOTTLE, GLASS in 1 CARTON (68982-822-01) / 10 mL in 1 BOTTLE, GLASS (68982-822-81) 2018-11-120000-00-00NoNoCurrent
68982-822-02689820822021 BOTTLE, GLASS in 1 CARTON (68982-822-02) / 25 mL in 1 BOTTLE, GLASS (68982-822-82) 2018-11-120000-00-00NoNoCurrent
68982-822-03689820822031 BOTTLE, GLASS in 1 CARTON (68982-822-03) / 50 mL in 1 BOTTLE, GLASS (68982-822-83) 2018-11-120000-00-00NoNoCurrent
68982-822-04689820822041 BOTTLE, GLASS in 1 CARTON (68982-822-04) / 100 mL in 1 BOTTLE, GLASS (68982-822-84) 2018-11-120000-00-00NoNoCurrent
68982-822-05689820822051 BOTTLE, GLASS in 1 CARTON (68982-822-05) / 200 mL in 1 BOTTLE, GLASS (68982-822-85) 2018-11-120000-00-00NoNoCurrent
68982-822-06689820822061 BOTTLE, GLASS in 1 CARTON (68982-822-06) / 300 mL in 1 BOTTLE, GLASS (68982-822-86) 2018-11-120000-00-00NoNoCurrent
68982-822-816898208228110 mL in 1 BOTTLE, GLASS10 mlHistorical
68982-822-826898208228225 mL in 1 BOTTLE, GLASS25 mlHistorical
68982-822-836898208228350 mL in 1 BOTTLE, GLASS50 mlHistorical
68982-822-8468982082284100 mL in 1 BOTTLE, GLASS100 mlHistorical
68982-822-8568982082285200 mL in 1 BOTTLE, GLASS200 mlHistorical
68982-822-8668982082286300 mL in 1 BOTTLE, GLASS300 mlHistorical