NDC 68982-820-83 - Panzyga

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68982-820
Requested NDC
68982-820-83
Package NDCs from labels
68982-820-81, 68982-820-01, 68982-820-82, 68982-820-02, 68982-820-83, 68982-820-03, 68982-820-84, 68982-820-04, 68982-820-85, 68982-820-05, 68982-820-86, 68982-820-06
Manufacturer
Octapharma USA Inc
Effective date
2021-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Panzyga - Octapharma USA IncOctapharma USA Inc2021-02-15PLASMA DERIVATIVE

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
68982-820-01These 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
68982-820-02These 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
68982-820-03These 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
68982-820-04These 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
68982-820-05These 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
68982-820-06These 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 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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIVIGY kthmHUMAN IMMUNOGLOBULIN GKedrion S.p.A.6f1933e0-240f-48f4-b246-8a30e63a41602026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 66Y330CJHS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.