Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Terumo BCT, Ltd
Terumo BCT, Ltd
233649834
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Additive Formula 3
Product Details
NDC Product Code
14537-828Application Number
BN001214Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
July 18, 2018GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL
Additive Formula 3
Product Details
NDC Product Code
14537-824Application Number
BN001214Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
July 18, 2018GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL
Additive Formula 3
Product Details
NDC Product Code
14537-826Application Number
BN001214Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
July 18, 2018GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.1 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 0.41 g in 100 mL
Code: 593YOG76RNClass: ACTIBQuantity: 0.28 g in 100 mL
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 0.042 g in 100 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
AdenineActive
Code: JAC85A2161Class: ACTIBQuantity: 0.03 g in 100 mL
Gadofosveset trisodiumActive
Code: B22547B95KClass: ACTIMQuantity: 0.59 g in 100 mL
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
INDICATIONS & USAGE SECTION
Highlight: Use only with Trima Accel red blood cell (RBC) apheresis collections. (1)
1 INDICATIONS AND USAGE
Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]