Additive Formula 3

Basic Information

Product Name

Additive Formula 3

FDA Product Code

14537-833

Regulatory Information

NDC Product Code

14537-833

Application Number

BN001214

Marketing Category

C73594

Effective Date

December 15, 2021

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Sodium Chloride

Quantity: 0.41 g in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

Citric Acid Monohydrate

Quantity: 0.042 g in 100 mL

Code: 2968PHW8QP

Class Code: ACTIM

Adenine

Quantity: 0.03 g in 100 mL

Code: JAC85A2161

Class Code: ACTIB

Dextrose Monohydrate

Quantity: 1.1 g in 100 mL

Code: LX22YL083G

Class Code: ACTIB

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Quantity: 0.28 g in 100 mL

Code: 593YOG76RN

Class Code: ACTIB

Water

Code: 059QF0KO0R

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Quantity: 0.59 g in 100 mL

Code: B22547B95K

Class Code: ACTIM

Active Moieties

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

PHOSPHATE ION

Code: NK08V8K8HR

ADENINE

Code: JAC85A2161

CHLORIDE ION

Code: Q32ZN48698

Basic Information

Regulatory Information

Company Information

Active Ingredients

Water

Active Moieties

ANHYDROUS DEXTROSE

ANHYDROUS CITRIC ACID

PHOSPHATE ION

ADENINE

CHLORIDE ION