Home NDC 68516-5214-9 ALBUTEIN
Product NDC 68516-5214
Requested package NDC 68516-5214-9
11-digit product format 685165214
Labeler code 68516
Product ID 68516-5214_e078cf18-faac-4ebe-915a-acf9c1af960e
Type PLASMA DERIVATIVE
Nonproprietary name ALBUMIN (HUMAN)
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler GRIFOLS USA, LLC
Application BLA102478
Marketing category BLA
Marketing start 2022-03-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68516-5214 68516-5214-9 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68516-5214 68516-5214-9 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Additional Listing Data#
Finished product Yes
Brand name base ALBUTEIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUMIN HUMAN 12.5 g/250mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68516-5214-1 ALBUTEIN 1 in 1 CARTON INJECTION, SOLUTION 1 17 68516-5214-2 ALBUTEIN 1 in 1 CARTON INJECTION, SOLUTION 1 17 68516-5214-3 ALBUTEIN 250 mL in 1 VIAL INJECTION, SOLUTION 250 17 68516-5214-4 ALBUTEIN 500 mL in 1 VIAL INJECTION, SOLUTION 500 17 68516-5214-5 ALBUTEIN 1 in 1 CARTON INJECTION, SOLUTION 1 17 68516-5214-6 ALBUTEIN 50 mL in 1 VIAL INJECTION, SOLUTION 50 17 68516-5214-0 ALBUTEIN 2 in 1 CARTON INJECTION, SOLUTION 2 13 68516-5214-7 ALBUTEIN 250 mL in 1 BAG INJECTION, SOLUTION 250 13 68516-5214-8 ALBUTEIN 500 mL in 1 BAG INJECTION, SOLUTION 500 13 68516-5214-9 ALBUTEIN 4 in 1 CARTON INJECTION, SOLUTION 4 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Albumin (Human) ACTIVE INGREDIENT ZIF514RVZR ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3 Albumin (Human) ACTIVE MOIETY ZIF514RVZR ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3 Sodium Acetyltryptophanate INACTIVE INGREDIENT 3EN9H0M2FX ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3 Sodium Caprylate INACTIVE INGREDIENT 9XTM81VK2B ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3 Water INACTIVE INGREDIENT 059QF0KO0R ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68516-5214 ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 16 Current NDC, Legacy NDC, 6 package rows 20231108_9c45986e-4e62-4f7d-971c-bec74dc4d234.zip 68516-5214 ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC] 12 Current NDC, Legacy NDC, 4 package rows 20250406_a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 102478 Albutein Albumin (Human) 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1741406 albumin human, USP 50 MG/ML Injection [Albutein] SBD 9c45986e-4e62-4f7d-971c-bec74dc4d234 17 1741405 albumin human, USP 50 MG/ML Injection SCD 9c45986e-4e62-4f7d-971c-bec74dc4d234 17 1741406 Albutein 50 MG/ML Injection SY 9c45986e-4e62-4f7d-971c-bec74dc4d234 17 1741410 albumin human 5 % in 100 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741420 albumin human 5 % in 250 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741423 albumin human 5 % in 500 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 2669811 Albutein 5 % in 100 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741421 Albutein 5 % in 250 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741424 Albutein 5 % in 500 ML Injection PSN a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 2669811 100 ML albumin human, USP 50 MG/ML Injection [Albutein] SBD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741421 250 ML albumin human, USP 50 MG/ML Injection [Albutein] SBD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741424 500 ML albumin human, USP 50 MG/ML Injection [Albutein] SBD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741406 albumin human, USP 50 MG/ML Injection [Albutein] SBD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741410 100 ML albumin human, USP 50 MG/ML Injection SCD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741420 250 ML albumin human, USP 50 MG/ML Injection SCD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741423 500 ML albumin human, USP 50 MG/ML Injection SCD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741405 albumin human, USP 50 MG/ML Injection SCD a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 2669811 100 ML Albutein 50 MG/ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741420 albumin human 12.5 GM per 250 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741423 albumin human 25 GM per 500 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741410 albumin human 5 % per 100 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741420 albumin human 5 % per 250 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741423 albumin human 5 % per 500 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741410 albumin human 5 GM per 100 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741421 Albutein 12.5 GM per 250 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741424 Albutein 25 GM per 500 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 2669811 Albutein 5 % per 100 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741421 Albutein 5 % per 250 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741424 Albutein 5 % per 500 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 2669811 Albutein 5 GM per 100 ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13 1741406 Albutein 50 MG/ML Injection SY a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68516-5214-9 68516521409 4 BAG in 1 CARTON (68516-5214-9) > 250 mL in 1 BAG (68516-5214-7) 4 bag 2021-11-08 2023-11-15 No No Current