Home NDC 14537-817 ACD
Product NDC 14537-817
11-digit product format 145370817
Labeler code 14537
Product ID 14537-817_867eaa34-08fc-4e51-b16d-dc03c2154104
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Terumo BCT, Ltd.
Application BA010228
Marketing category ANDA
Marketing start 2002-02-25
Substance CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Active strength .8; 2.45; 2.2 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 2026-12-31
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 14537-817-75 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 14537-817-75 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base ACD
Brand name suffix A
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRIC ACID MONOHYDRATE .8 g/100mL DEXTROSE MONOHYDRATE 2.45 g/100mL TRISODIUM CITRATE DIHYDRATE 2.2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2968PHW8QP Internal UNII lookup LX22YL083G Internal UNII lookup B22547B95K Internal UNII lookup
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 14537-817-75 ACD A 750 mL in 1 BAG INJECTION, SOLUTION 750 5 14537-817-75 ACD A 12 in 1 CARTON INJECTION, SOLUTION 12 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14537-817 ACD A (CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE) INJECTION, SOLUTION [TERUMO BCT, LTD.] 5 Current NDC, Legacy NDC, 2 package rows 20250124_395aec48-198a-4aed-8e38-7accfb3232f9.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ACD A CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE Terumo BCT, Ltd. 395aec48-198a-4aed-8e38-7accfb3232f9 2026-06-15 Warnings, Adverse reactions Exact identifier application number: BA010228 ndc (product): 14537-817 ACD A CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE Terumo BCT, Ltd 8e255bc7-a120-460a-a32d-43931f8115de 2026-05-21 Warnings, Adverse reactions Exact identifier application number: BA010228 ACD A DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE Terumo BCT Ltd 570770de-9b48-4fc1-a1ee-06002ca9504f 2025-01-22 Exact identifier application number: BA010228
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14537-817-75 14537081775 12 BAG in 1 CARTON (14537-817-75) / 750 mL in 1 BAG 12 bag 2002-02-25 0000-00-00 No No Current