FDA.reportPublic FDA data

NDC 68516-5216-4 - ALBUTEIN

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
68516-5216
Requested NDC
68516-5216-4
Package NDCs from labels
68516-5216-3, 68516-5216-1, 68516-5216-4, 68516-5216-2, 68516-5216-6, 68516-5216-5, 68516-5216-7, 68516-5216-9, 68516-5216-8, 68516-5216-0
Manufacturer
GRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SA
Effective date
2025-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALBUTEIN - GRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SAGRIFOLS USA, LLC | Grifols Biologicals LLC | Grifols Therapeutics LLC | INSTITUTO GRIFOLS SA2025-05-28PLASMA DERIVATIVE
ALBUTEIN - GRIFOLS USA, LLC | Grifols Biologicals LLCGRIFOLS USA, LLC | Grifols Biologicals LLC2025-05-28PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-5216-1ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5216-2ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5216-3ALBUTEIN50 mL in 1 VIALINJECTION, SOLUTION5017
68516-5216-4ALBUTEIN100 mL in 1 VIALINJECTION, SOLUTION10017
68516-5216-5ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5216-6ALBUTEIN20 mL in 1 VIALINJECTION, SOLUTION2017
68516-5216-0ALBUTEIN5 in 1 CARTONINJECTION, SOLUTION510
68516-5216-7ALBUTEIN50 mL in 1 BAGINJECTION, SOLUTION5010
68516-5216-8ALBUTEIN100 mL in 1 BAGINJECTION, SOLUTION10010
68516-5216-9ALBUTEIN5 in 1 CARTONINJECTION, SOLUTION510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-5216ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]16Current NDC, Legacy NDC, 6 package rows20231102_de634e31-d99b-4ed6-ba0a-07904d745aeb.zip
68516-5216ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]9Current NDC, Legacy NDC, 4 package rows20240106_a7dae31a-e41d-4bfa-9c0a-060d6e91627b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-5216-0ML - Milliliter68516-52160b985cf2-86c8-4c33-bb3b-14d184ed15fc12022-04-06
68516-5216-1ML - Milliliter68516-5216736e6b0a-c975-4c1d-ac5e-7f69d227bec212012-07-24
68516-5216-2ML - Milliliter68516-52163b09760f-a0e9-4230-a1c3-3322af0cd35712012-07-24
68516-5216-3ML - Milliliter68516-521648942661-8765-42f9-a2f4-36dd3eef452a12014-10-03
68516-5216-4ML - Milliliter68516-52168c64bd3e-8092-45bb-acb3-25506d9f139512014-10-03
68516-5216-5ML - Milliliter68516-5216d90271db-2597-4464-b317-f5dd0be1ee4b12016-07-19
68516-5216-6ML - Milliliter68516-52163150fab6-3a7a-4da3-a947-55ac05be4a0412016-07-19
68516-5216-7ML - Milliliter68516-5216029fc37a-c257-4bd2-a9b0-7c547c3e5d7e12021-04-08
68516-5216-8ML - Milliliter68516-521655098e5b-4a23-4086-a3a5-6980a9a1e03712021-04-08
68516-5216-9ML - Milliliter68516-5216b4707c3a-a7fd-4783-b676-b5e9773fbec812022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albumin (Human)ACTIVE INGREDIENTZIF514RVZRALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3
Albumin (Human)ACTIVE MOIETYZIF514RVZRALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3
Sodium AcetyltryptophanateINACTIVE INGREDIENT3EN9H0M2FXALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3
Sodium CaprylateINACTIVE INGREDIENT9XTM81VK2BALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]3

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 3 of 51 · 1,019 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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