FDA.reportPublic FDA data

Panzyga

Product NDC
68982-820
Requested package NDC
68982-820-01
11-digit product format
689820820
Labeler code
68982
Product ID
68982-820_9f78508b-2dbf-5d6e-85e8-4f60d87bc562
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
Marketing end
0000-00-00
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
100 mg/mL
Pharmacologic classes
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68982-82068982-820-01IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68982-820-012023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018
68982-820-022023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018
68982-820-032023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018
68982-820-042023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018
68982-820-052023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018
68982-820-062023-01-30C16284748780-1f386c649-d909-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANZYGA safely and effectively. See full prescribing information for PANZYGA. PANZYGA, (immune globulin intravenous, human - ifas) 10% Liquid Preparation Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-820-01Panzyga1 in 1 CARTONSOLUTION111
68982-820-02Panzyga1 in 1 CARTONSOLUTION111
68982-820-03Panzyga1 in 1 CARTONSOLUTION111
68982-820-04Panzyga1 in 1 CARTONSOLUTION111
68982-820-05Panzyga1 in 1 CARTONSOLUTION111
68982-820-06Panzyga1 in 1 CARTONSOLUTION111
68982-820-81Panzyga10 mL in 1 BOTTLE, GLASSSOLUTION1011
68982-820-82Panzyga25 mL in 1 BOTTLE, GLASSSOLUTION2511
68982-820-83Panzyga50 mL in 1 BOTTLE, GLASSSOLUTION5011
68982-820-84Panzyga100 mL in 1 BOTTLE, GLASSSOLUTION10011
68982-820-85Panzyga200 mL in 1 BOTTLE, GLASSSOLUTION20011
68982-820-86Panzyga300 mL in 1 BOTTLE, GLASSSOLUTION30011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-820-01ML - Milliliter68982-82066d30735-0320-4257-b9b9-91bdeda51cf812018-12-13
68982-820-02ML - Milliliter68982-8209c8a7446-5e08-4b2a-9f15-bd8e9593c02212018-12-13
68982-820-03ML - Milliliter68982-8204a6ae20b-6def-46ea-a20c-c7604a94022a12018-12-13
68982-820-04ML - Milliliter68982-8200c778b8f-96b1-4e70-b14c-5255d1bdf66d12018-12-13
68982-820-05ML - Milliliter68982-820c78a26f5-86fd-4a31-8805-665efe967e9c12018-12-13
68982-820-06ML - Milliliter68982-820b3e124eb-9caa-455f-8a34-20112312debe12018-12-13
68982-820-81ML - Milliliter68982-8209170ca11-52e0-4937-ad5f-816c7ab6957012018-11-06
68982-820-82ML - Milliliter68982-82030a25a8c-f49a-440c-846d-b4c163df80db12018-11-06
68982-820-83ML - Milliliter68982-8202a8df736-a55d-4586-a6b9-f7c2b9b8fb6712018-11-06
68982-820-84ML - Milliliter68982-820e98bbcff-01ae-4201-a7dc-52c4c91112c212018-11-06
68982-820-85ML - Milliliter68982-8200c774f5f-1e8a-4c6f-ae7e-a9f7fa7cc4ca12018-11-06
68982-820-86ML - Milliliter68982-8202741371a-6b6b-4786-a27e-002edd13957a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-820PANZYGA (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) SOLUTION [OCTAPHARMA USA INC]11Legacy NDC, 12 package rows20210227_68a5ee5f-0352-b3ae-3321-c0a22947a31d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125587PanzygaImmune Globulin Intravenous (Human)-ifas351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102435immune globulin intravenous (human) - ifas 10 % in 10 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102463immune globulin intravenous (human) - ifas 10 % in 100 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102469immune globulin intravenous (human) - ifas 10 % in 200 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102455immune globulin intravenous (human) - ifas 10 % in 25 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102471immune globulin intravenous (human) - ifas 10 % in 300 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102459immune globulin intravenous (human) - ifas 10 % in 50 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102440panzyga 10 % in 10 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102464panzyga 10 % in 100 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102470panzyga 10 % in 200 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102456panzyga 10 % in 25 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102472panzyga 10 % in 300 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102460panzyga 10 % in 50 ML InjectionPSN68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210244010 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102464100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102470200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210245625 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102472300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210246050 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga]SBD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210243510 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102463100 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102469200 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210245525 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102471300 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210245950 ML immune globulin intravenous (human) - ifas 100 MG/ML InjectionSCD68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210244010 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102464100 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102470200 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210245625 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102472300 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
210246050 ML Panzyga 100 MG/ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102435immune globulin intravenous (human) - ifas 10 % per 10 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102463immune globulin intravenous (human) - ifas 10 % per 100 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102469immune globulin intravenous (human) - ifas 10 % per 200 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102455immune globulin intravenous (human) - ifas 10 % per 25 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102471immune globulin intravenous (human) - ifas 10 % per 300 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102459immune globulin intravenous (human) - ifas 10 % per 50 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102440Panzyga 10 % per 10 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102464Panzyga 10 % per 100 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102470Panzyga 10 % per 200 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102456Panzyga 10 % per 25 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102472Panzyga 10 % per 300 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11
2102460Panzyga 10 % per 50 ML InjectionSY68a5ee5f-0352-b3ae-3321-c0a22947a31d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68982-820-01689820820011 BOTTLE, GLASS in 1 CARTON (68982-820-01) > 10 mL in 1 BOTTLE, GLASS (68982-820-81) 2018-11-120000-00-00NoNoCurrent