FDA.reportPublic FDA data

ALBUTEIN

Product NDC
68516-5218
11-digit product format
685165218
Labeler code
68516
Product ID
68516-5218_e25389c6-23b5-4bc9-8054-f4782145cffe
Type
PLASMA DERIVATIVE
Nonproprietary name
ALBUMIN (HUMAN)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA102478
Marketing category
BLA
Marketing start
2023-11-15
Substance
ALBUMIN HUMAN
Active strength
12.5 g/250mL
Pharmacologic classes
Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALBUTEIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN12.5 g/250mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-5218-0ALBUTEIN250 mL in 1 BAGINJECTION, SOLUTION25013
68516-5218-1ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION113
68516-5218-4ALBUTEIN4 in 1 CARTONINJECTION, SOLUTION413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-5218-0ML - Milliliter68516-52189f41b969-7e69-46de-b64d-8ecedf2f025312023-09-05
68516-5218-4ML - Milliliter68516-5218ca6fc233-0fb8-44b7-988b-cce62285c80b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-5218ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]12Current NDC, 3 package rows20250406_a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741410albumin human 5 % in 100 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741420albumin human 5 % in 250 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741423albumin human 5 % in 500 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
2669811Albutein 5 % in 100 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741421Albutein 5 % in 250 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741424Albutein 5 % in 500 ML InjectionPSNa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
2669811100 ML albumin human, USP 50 MG/ML Injection [Albutein]SBDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741421250 ML albumin human, USP 50 MG/ML Injection [Albutein]SBDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741424500 ML albumin human, USP 50 MG/ML Injection [Albutein]SBDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741406albumin human, USP 50 MG/ML Injection [Albutein]SBDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741410100 ML albumin human, USP 50 MG/ML InjectionSCDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741420250 ML albumin human, USP 50 MG/ML InjectionSCDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741423500 ML albumin human, USP 50 MG/ML InjectionSCDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741405albumin human, USP 50 MG/ML InjectionSCDa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
2669811100 ML Albutein 50 MG/ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741420albumin human 12.5 GM per 250 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741423albumin human 25 GM per 500 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741410albumin human 5 % per 100 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741420albumin human 5 % per 250 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741423albumin human 5 % per 500 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741410albumin human 5 GM per 100 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741421Albutein 12.5 GM per 250 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741424Albutein 25 GM per 500 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
2669811Albutein 5 % per 100 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741421Albutein 5 % per 250 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741424Albutein 5 % per 500 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
2669811Albutein 5 GM per 100 ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513
1741406Albutein 50 MG/ML InjectionSYa6ca2871-9a9d-4f03-a5ff-ddb28c6ff94513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68516-5218-068516521800250 mL in 1 BAG250 mlHistorical
68516-5218-1685165218011 BAG in 1 CARTON (68516-5218-1) / 250 mL in 1 BAG (68516-5218-0) 1 bag2023-11-15NoNoHistorical
68516-5218-4685165218044 BAG in 1 CARTON (68516-5218-4) / 250 mL in 1 BAG (68516-5218-0) 4 bag2023-11-15NoNoHistorical