FDA.reportPublic FDA data

NDC 0944-2884-06 - GLASSIA

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
0944-2884
Requested NDC
0944-2884-06
Package NDCs from labels
0944-2884-02, 0944-2884-01, 0944-2884-04, 0944-2884-03, 0944-2884-06, 0944-2884-05
Manufacturer
Takeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | BAXALTA US INC. | SGS Lab Simon | Takeda Manufacturing Austria AG
Effective date
2025-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLASSIATakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | BAXALTA US INC. | SGS Lab Simon | Takeda Manufacturing Austria AG2025-12-02PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2884-01GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-02GLASSIA50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5031
0944-2884-03GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-04GLASSIA200 mL in 1 VIAL, GLASSINJECTION, SOLUTION20031
0944-2884-05GLASSIA1 in 1 CARTONINJECTION, SOLUTION131
0944-2884-06GLASSIA250 mL in 1 VIAL, GLASSINJECTION, SOLUTION25031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2884GLASSIA (ALPHA.1-PROTEINASE INHIBITOR HUMAN) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]30Current NDC, Legacy NDC, 6 package rows20250316_83473cbb-48e4-42a2-81b6-4c851423da7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2884-01EA - Each0944-28846234ccee-dced-4f84-83a1-e59f978225ba12012-07-24
0944-2884-02EA - Each0944-28845252d354-be53-4254-8d30-7e6e97734deb12019-02-13
0944-2884-03EA - Each0944-28843964a5f2-6a41-4997-9104-91a8db75382012025-07-08
0944-2884-04EA - Each0944-288479eb1c4f-ccf8-4200-88b7-99d095367daf12025-07-08
0944-2884-05EA - Each0944-28842250c3e7-3825-480f-a70a-de809db23dd412025-07-08
0944-2884-06EA - Each0944-288430c550c7-f6c8-4996-8f2f-f4b5f3501c6b12025-07-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE INGREDIENTF43I396OISGLASSIA (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE MOIETYF43I396OISGLASSIA (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGLASSIA (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956GLASSIA (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16
WATERINACTIVE INGREDIENT059QF0KO0RGLASSIA (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]16

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 18 of 51 · 1,019 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.5f372b75-d7a4-471e-8ac6-290040fc84b02025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.243fe8fc-996a-4855-8daf-069628e547c42025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEICU Medical Inc.d310d170-5eeb-471b-af1a-0e845001d21d2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Family Care SalineSODIUM CHLORIDEUnited Exchange Corp.06737393-d4ae-3e7b-e063-6394a90ac19f2025-10-31WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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