Anticoagulant Sodium Citrate

Product NDC
62646-798
11-digit product format
626460798
Labeler code
62646
Product ID
62646-798_a083fb8e-3012-4d12-94d3-949a3188aba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Citrate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Medsep Corporation
Application
NDA760305
Marketing category
NDA
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
SODIUM CITRATE
Active strength
10 g/250mL
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62646-798IInactivated by FDA2026-07-31
excluded packagepackage62646-79862646-798-60IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62646-798-602019-10-29C16284748780-1960f7f55-c506-8e05-e053-dbdaa90a074aAnticoagulant Sodium Citrate Solution, USP Code 798-60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62646-798-60Anticoagulant Sodium Citrate250 mL in 1 BAGSOLUTION2504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]4
CITRIC ACID ANHYDROUSACTIVE MOIETYXF417D3PSLANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62646-798ANTICOAGULANT SODIUM CITRATE (SODIUM CITRATE) SOLUTION [MEDSEP CORPORATION]4Legacy NDC, 1 package rows20120613_3a8dfcfa-e034-40ca-a71f-05099015f87d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
62646-798-6062646079860250 mL in 1 BAG250 mlHistorical