Home NDC 14537-967 ACD
Product NDC 14537-967
11-digit product format 145370967
Labeler code 14537
Product ID 14537-967_b4f43833-2089-467d-bfd3-03817b19cab6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate
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; SODIUM CITRATE, UNSPECIFIED FORM
Active strength .8; 2.45; 2.2 g/100mL; g/100mL; g/100mL
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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 14537-967-75 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 14537-967-75 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base ACD
Brand name suffix A
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE .8 g/100mL SODIUM CITRATE, UNSPECIFIED FORM 2.45 g/100mL CITRIC ACID MONOHYDRATE 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 LX22YL083G Internal UNII lookup 1Q73Q2JULR Internal UNII lookup 2968PHW8QP 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 14537-967-75 ACD A 750 mL in 1 BAG INJECTION, SOLUTION 750 5 14537-967-75 ACD A 12 in 1 CASE INJECTION, SOLUTION 12 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Citric Acid Monohydrate ACTIVE INGREDIENT 2968PHW8QP ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2 Dextrose Monohydrate ACTIVE INGREDIENT LX22YL083G ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2 Sodium Citrate ACTIVE INGREDIENT 1Q73Q2JULR ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2 Anhydrous Citric Acid ACTIVE MOIETY XF417D3PSL ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2 Anhydrous Dextrose ACTIVE MOIETY 5SL0G7R0OK ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2 Sodium Cation ACTIVE MOIETY LYR4M0NH37 ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14537-967 ACD A (DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) INJECTION, SOLUTION [TERUMO BCT LTD] 5 Current NDC, Legacy NDC, 2 package rows 20250124_570770de-9b48-4fc1-a1ee-06002ca9504f.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 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 ndc (product): 14537-967
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14537-967-75 14537096775 12 BAG in 1 CASE (14537-967-75) / 750 mL in 1 BAG 12 bag 2002-02-25 0000-00-00 No No Current