FDA.reportPublic FDA data

ALBUTEIN

Product NDC
68516-5216
11-digit product format
685165216
Labeler code
68516
Product ID
68516-5216_185395b1-8739-4a37-8d2a-719bdd12bb3e
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/50mL
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/50mL

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741380albumin human 25 % in 100 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741570albumin human 25 % in 20 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741375albumin human 25 % in 50 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741381Albutein 25 % in 100 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1798549Albutein 25 % in 20 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741377Albutein 25 % in 50 ML InjectionPSNde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741381100 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDde634e31-d99b-4ed6-ba0a-07904d745aeb17
179854920 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDde634e31-d99b-4ed6-ba0a-07904d745aeb17
174137750 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741380100 ML albumin human, USP 250 MG/ML InjectionSCDde634e31-d99b-4ed6-ba0a-07904d745aeb17
174157020 ML albumin human, USP 250 MG/ML InjectionSCDde634e31-d99b-4ed6-ba0a-07904d745aeb17
174137550 ML albumin human, USP 250 MG/ML InjectionSCDde634e31-d99b-4ed6-ba0a-07904d745aeb17
179854920 ML Albutein 250 MG/ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741375albumin human 12.5 GM per 50 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741380albumin human 25 % per 100 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741570albumin human 25 % per 20 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741375albumin human 25 % per 50 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741380albumin human 25 GM per 100 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741570albumin human 5 GM per 20 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741377Albutein 12.5 GM per 50 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741381Albutein 25 % per 100 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1798549Albutein 25 % per 20 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741377Albutein 25 % per 50 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741381Albutein 25 GM per 100 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1798549Albutein 250 MG/ML per 20 ML InjectionSYde634e31-d99b-4ed6-ba0a-07904d745aeb17
1741380albumin human 25 % in 100 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741570albumin human 25 % in 20 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741375albumin human 25 % in 50 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741381Albutein 25 % in 100 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1798549Albutein 25 % in 20 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741377Albutein 25 % in 50 ML InjectionPSNa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741381100 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
179854920 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
174137750 ML albumin human, USP 250 MG/ML Injection [Albutein]SBDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741380100 ML albumin human, USP 250 MG/ML InjectionSCDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
174157020 ML albumin human, USP 250 MG/ML InjectionSCDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
174137550 ML albumin human, USP 250 MG/ML InjectionSCDa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
179854920 ML Albutein 250 MG/ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741375albumin human 12.5 GM per 50 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741380albumin human 25 % per 100 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741570albumin human 25 % per 20 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741375albumin human 25 % per 50 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741380albumin human 25 GM per 100 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741570albumin human 5 GM per 20 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741377Albutein 12.5 GM per 50 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741381Albutein 25 % per 100 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1798549Albutein 25 % per 20 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741377Albutein 25 % per 50 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1741381Albutein 25 GM per 100 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10
1798549Albutein 250 MG/ML per 20 ML InjectionSYa7dae31a-e41d-4bfa-9c0a-060d6e91627b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68516-5216-0685165216005 BAG in 1 CARTON (68516-5216-0) / 100 mL in 1 BAG (68516-5216-8) 5 bag2022-03-010000-00-00NoNoCurrent
68516-5216-1685165216011 VIAL in 1 CARTON (68516-5216-1) / 50 mL in 1 VIAL (68516-5216-3) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5216-2685165216021 VIAL in 1 CARTON (68516-5216-2) / 100 mL in 1 VIAL (68516-5216-4) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5216-36851652160350 mL in 1 VIAL50 mlHistorical
68516-5216-468516521604100 mL in 1 VIAL100 mlHistorical
68516-5216-5685165216051 VIAL in 1 CARTON (68516-5216-5) / 20 mL in 1 VIAL (68516-5216-6) 1 vial2022-03-010000-00-00NoNoCurrent
68516-5216-66851652160620 mL in 1 VIAL20 mlHistorical
68516-5216-76851652160750 mL in 1 BAG (68516-5216-7) 50 ml2019-12-150000-00-00NoNoCurrent
68516-5216-868516521608100 mL in 1 BAG (68516-5216-8) 100 ml2019-12-150000-00-00NoNoCurrent
68516-5216-9685165216095 BAG in 1 CARTON (68516-5216-9) / 50 mL in 1 BAG (68516-5216-7) 5 bag2022-03-010000-00-00NoNoCurrent