Home NDC 17856-0595 Sodium Citrate and Citric Acid
Product NDC 17856-0595
11-digit product format 178560595
Labeler code 17856
Product ID 17856-0595_4974ca9f-b5e3-870d-e063-6294a90a26c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corp.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1969-01-01
Substance SODIUM CITRATE; ANHYDROUS CITRIC ACID
Active strength 500; 334 mg/5mL; mg/5mL
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0595-4 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0595-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0595-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-0595-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-0595-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Citrate and Citric Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CITRATE 500 mg/5mL ANHYDROUS CITRIC ACID 334 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Q73Q2JULR Internal UNII lookup XF417D3PSL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0595-1 Sodium Citrate and Citric Acid 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 8 17856-0595-1 Sodium Citrate and Citric Acid 72 in 1 CASE SOLUTION 72 8 17856-0595-3 Sodium Citrate and Citric Acid 30 mL in 1 CUP SOLUTION 30 8 17856-0595-3 Sodium Citrate and Citric Acid 50 in 1 CASE SOLUTION 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0595 SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [ATLANTIC BIOLOGICALS CORP.] 7 Current NDC, Legacy NDC, 4 package rows 20250525_42d837ae-2578-46df-92d2-24774964aaad.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17856-0595-1 17856059501 72 CUP, UNIT-DOSE in 1 CASE (17856-0595-1) / 15 mL in 1 CUP, UNIT-DOSE 2024-04-18 No No Current 17856-0595-3 17856059503 50 CUP in 1 CASE (17856-0595-3) / 30 mL in 1 CUP 50 cup 2024-04-18 0000-00-00 No No Current 17856-0595-4 17856059504 1 CASE in 1 CUP, UNIT-DOSE (17856-0595-4) > 50 CUP in 1 CASE (17856-0595-3) > 30 mL in 1 CUP 1 case 2022-09-02 0000-00-00 No No Current 17856-0595-5 17856059505 1 CASE in 1 CUP, UNIT-DOSE (17856-0595-5) > 72 CUP, UNIT-DOSE in 1 CASE (17856-0595-1) > 15 mL in 1 CUP, UNIT-DOSE 1 case 2022-09-02 0000-00-00 No No Current