AS
Additive Solution Formula 3
Approved
Approval ID
5f51ab45-2ff0-4b07-9fb9-69789da65d4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2018
Manufacturers
FDA
Terumo BCT Ltd
DUNS: 233649834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14537-966
Application NumberBN001214
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2018
FDA Product Classification
INGREDIENTS (6)
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: 0.276 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
SODIUM CITRATE, UNSPECIFIED FORMActive
Quantity: 0.588 g in 100 mL
Code: 1Q73Q2JULR
Classification: ACTIB