Home NDC 14537-833 Additive Formula 3
Product NDC 14537-833
11-digit product format 145370833
Labeler code 14537
Product ID 14537-833_a93abdba-f409-4b1b-b0d7-ece2189573d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Terumo BCT, Ltd
Application BN001214
Marketing category NDA
Marketing start 2002-05-29
Substance ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Active strength .03; .042; 1.1; .41; .28; .59 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 14537-833-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 14537-833-03 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Additive Formula 3
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE .03 g/100mL TRISODIUM CITRATE DIHYDRATE .042 g/100mL SODIUM CHLORIDE 1.1 g/100mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .41 g/100mL CITRIC ACID MONOHYDRATE .28 g/100mL ADENINE .59 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 14537-833-00 Additive Formula 3 200 mL in 1 BAG SOLUTION 200 3 14537-833-03 Additive Formula 3 30 in 1 CASE SOLUTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14537-833 ADDITIVE FORMULA 3 (DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE) SOLUTION [TERUMO BCT, LTD] 2 Current NDC, Legacy NDC, 2 package rows 20250126_9a5247a1-cc05-442d-b2d0-950f887f03c2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Additive Formula 3 DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE Terumo BCT, Ltd 9a5247a1-cc05-442d-b2d0-950f887f03c2 2026-01-30 Warnings, Adverse reactions Exact identifier application number: BN001214 ndc (product): 14537-833
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14537-833-00 14537083300 200 mL in 1 BAG 200 ml Historical 14537-833-03 14537083303 30 BAG in 1 CASE (14537-833-03) / 200 mL in 1 BAG (14537-833-00) 30 bag 2002-05-29 0000-00-00 No No Current