Additive Formula 3
These highlights do not include all the information needed to use ADDITIVE SOLUTION FORMULA 3 (AS-3) safely and effectively. See full prescribing information for ADDITIVE SOLUTION FORMULA 3 (AS-3). ADDITIVE SOLUTION FORMULA 3 (AS-3) Sterile Fluid Polyolefin Bag Initial U.S. Approval: 2002
Approved
Approval ID
9a5247a1-cc05-442d-b2d0-950f887f03c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2021
Manufacturers
FDA
Terumo BCT, Ltd
DUNS: 233649834
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14537-833
Application NumberBN001214
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (7)
Sodium ChlorideActive
Quantity: 0.41 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
Citric Acid MonohydrateActive
Quantity: 0.042 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
AdenineActive
Quantity: 0.03 g in 100 mL
Code: JAC85A2161
Classification: ACTIB
Dextrose MonohydrateActive
Quantity: 1.1 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.28 g in 100 mL
Code: 593YOG76RN
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 0.59 g in 100 mL
Code: B22547B95K
Classification: ACTIM
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14537-834
Application NumberBN001214
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (7)
Dextrose MonohydrateActive
Quantity: 1.1 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
Sodium ChlorideActive
Quantity: 0.41 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.28 g in 100 mL
Code: 593YOG76RN
Classification: ACTIB
Citric Acid MonohydrateActive
Quantity: 0.042 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
AdenineActive
Quantity: 0.03 g in 100 mL
Code: JAC85A2161
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 0.59 g in 100 mL
Code: B22547B95K
Classification: ACTIM
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14537-832
Application NumberBN001214
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (7)
Sodium ChlorideActive
Quantity: 0.41 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Dextrose MonohydrateActive
Quantity: 1.1 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEActive
Quantity: 0.28 g in 100 mL
Code: 593YOG76RN
Classification: ACTIB
Citric Acid MonohydrateActive
Quantity: 0.042 g in 100 mL
Code: 2968PHW8QP
Classification: ACTIM
AdenineActive
Quantity: 0.03 g in 100 mL
Code: JAC85A2161
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 0.59 g in 100 mL
Code: B22547B95K
Classification: ACTIM