FDA.reportPublic FDA data

ALBUTEIN

Product NDC
68516-5214
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

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
68516-5214-1ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5214-2ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5214-3ALBUTEIN250 mL in 1 VIALINJECTION, SOLUTION25017
68516-5214-4ALBUTEIN500 mL in 1 VIALINJECTION, SOLUTION50017
68516-5214-5ALBUTEIN1 in 1 CARTONINJECTION, SOLUTION117
68516-5214-6ALBUTEIN50 mL in 1 VIALINJECTION, SOLUTION5017
68516-5214-0ALBUTEIN2 in 1 CARTONINJECTION, SOLUTION213
68516-5214-7ALBUTEIN250 mL in 1 BAGINJECTION, SOLUTION25013
68516-5214-8ALBUTEIN500 mL in 1 BAGINJECTION, SOLUTION50013
68516-5214-9ALBUTEIN4 in 1 CARTONINJECTION, SOLUTION413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-5214-0ML - Milliliter68516-5214c95a1501-c502-4b77-ad00-ad19e53d8b8212021-12-08
68516-5214-1ML - Milliliter68516-52147a55218d-41af-4c23-8aa0-f1931642647a12012-07-24
68516-5214-2ML - Milliliter68516-52147cc5cefc-1bc3-44f3-a6cb-ac03a9e917fc12012-07-24
68516-5214-3ML - Milliliter68516-52144519dd7e-f0f9-4663-a534-db77235c442912014-10-03
68516-5214-4ML - Milliliter68516-5214780e43ea-0794-4862-aefd-e766ade037c112014-10-03
68516-5214-5ML - Milliliter68516-52145c6eb1af-1152-48a4-b5bf-a616bfe2e01f12016-07-19
68516-5214-6ML - Milliliter68516-521451b3a042-515f-4d1a-a3dd-9118ecb6b7e612016-07-19
68516-5214-7ML - Milliliter68516-521424fc8f17-29aa-42aa-9ea9-c916c1ca9f5912021-12-08
68516-5214-8ML - Milliliter68516-5214c46f6074-a864-4a39-a729-36a796efa75d12021-12-08
68516-5214-9ML - Milliliter68516-52145c158552-cc7f-41ce-b467-ea433c5f982e12021-12-08

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-5214ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]16Current NDC, Legacy NDC, 6 package rows20231108_9c45986e-4e62-4f7d-971c-bec74dc4d234.zip
68516-5214ALBUTEIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [GRIFOLS USA, LLC]12Current NDC, Legacy NDC, 4 package rows20250406_a6ca2871-9a9d-4f03-a5ff-ddb28c6ff945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741406albumin human, USP 50 MG/ML Injection [Albutein]SBD9c45986e-4e62-4f7d-971c-bec74dc4d23417
1741405albumin human, USP 50 MG/ML InjectionSCD9c45986e-4e62-4f7d-971c-bec74dc4d23417
1741406Albutein 50 MG/ML InjectionSY9c45986e-4e62-4f7d-971c-bec74dc4d23417
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 startMarketing endSampleExclude flagStatus
68516-5214-0685165214002 BAG in 1 CARTON (68516-5214-0) > 500 mL in 1 BAG (68516-5214-8) 2 bag2021-11-080000-00-00NoNoCurrent
68516-5214-1685165214011 VIAL in 1 CARTON (68516-5214-1) / 250 mL in 1 VIAL (68516-5214-3) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5214-2685165214021 VIAL in 1 CARTON (68516-5214-2) / 500 mL in 1 VIAL (68516-5214-4) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5214-368516521403250 mL in 1 VIAL250 mlHistorical
68516-5214-468516521404500 mL in 1 VIAL500 mlHistorical
68516-5214-5685165214051 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5214-66851652140650 mL in 1 VIAL50 mlHistorical
68516-5214-768516521407250 mL in 1 BAG250 mlHistorical
68516-5214-868516521408500 mL in 1 BAG500 mlHistorical
68516-5214-9685165214094 BAG in 1 CARTON (68516-5214-9) > 250 mL in 1 BAG (68516-5214-7) 4 bag2021-11-080000-00-00NoNoCurrent