additive formula 3

Generic: dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine

Labeler: terumo bct, ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name additive formula 3
Generic Name dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine
Labeler terumo bct, ltd
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

adenine .03 g/100mL, citric acid monohydrate .042 g/100mL, dextrose monohydrate 1.1 g/100mL, sodium chloride .41 g/100mL, sodium phosphate, monobasic, monohydrate .28 g/100mL, trisodium citrate dihydrate .59 g/100mL

Manufacturer
Terumo BCT, Ltd

Identifiers & Regulatory

Product NDC 14537-832
Product ID 14537-832_a93abdba-f409-4b1b-b0d7-ece2189573d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number BN001214
Listing Expiration 2027-12-31
Marketing Start 2002-05-29

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14537832
Hyphenated Format 14537-832

Supplemental Identifiers

UNII
JAC85A2161 593YOG76RN 2968PHW8QP 451W47IQ8X B22547B95K LX22YL083G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name additive formula 3 (source: ndc)
Generic Name dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine (source: ndc)
Application Number BN001214 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .03 g/100mL
  • .042 g/100mL
  • 1.1 g/100mL
  • .41 g/100mL
  • .28 g/100mL
  • .59 g/100mL
source: ndc
Packaging
  • 6 POUCH in 1 CASE (14537-832-03) / 6 BAG in 1 POUCH (14537-832-01) / 100 mL in 1 BAG (14537-832-00)
source: ndc

Packages (1)

14537-832-03 6 POUCH in 1 CASE (14537-832-03) / 6 BAG in 1 POUCH (14537-832-01) / 100 mL in 1 BAG (14537-832-00)

Ingredients (6)

adenine (.03 g/100mL) citric acid monohydrate (.042 g/100mL) dextrose monohydrate (1.1 g/100mL) sodium chloride (.41 g/100mL) sodium phosphate, monobasic, monohydrate (.28 g/100mL) trisodium citrate dihydrate (.59 g/100mL)

Linked Drug Pages (1)

Additive Formula 3 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a93abdba-f409-4b1b-b0d7-ece2189573d9", "openfda": {"unii": ["JAC85A2161", "593YOG76RN", "2968PHW8QP", "451W47IQ8X", "B22547B95K", "LX22YL083G"], "spl_set_id": ["9a5247a1-cc05-442d-b2d0-950f887f03c2"], "manufacturer_name": ["Terumo BCT, Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CASE (14537-832-03)  / 6 BAG in 1 POUCH (14537-832-01)  / 100 mL in 1 BAG (14537-832-00)", "package_ndc": "14537-832-03", "marketing_start_date": "20020529"}], "brand_name": "Additive Formula 3", "product_id": "14537-832_a93abdba-f409-4b1b-b0d7-ece2189573d9", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "14537-832", "generic_name": "Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine", "labeler_name": "Terumo BCT, Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Additive Formula 3", "active_ingredients": [{"name": "ADENINE", "strength": ".03 g/100mL"}, {"name": "CITRIC ACID MONOHYDRATE", "strength": ".042 g/100mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "1.1 g/100mL"}, {"name": "SODIUM CHLORIDE", "strength": ".41 g/100mL"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "strength": ".28 g/100mL"}, {"name": "TRISODIUM CITRATE DIHYDRATE", "strength": ".59 g/100mL"}], "application_number": "BN001214", "marketing_category": "NDA", "marketing_start_date": "20020529", "listing_expiration_date": "20271231"}