Haemonetics Additive Solution Formula 3 (AS-3)

Product NDC
57826-460
11-digit product format
578260460
Labeler code
57826
Product ID
57826-460_af0c5490-6267-ef76-e053-2995a90ae68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE
Dosage form
SOLUTION
Route
EXTRACORPOREAL
Labeler
Haemonetics Corporation
Application
BN000127
Marketing category
NDA
Marketing start
2013-01-10
Marketing end
0000-00-00
Substance
CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM CHLORIDE; ADENINE; ANHYDROUS DEXTROSE; TRISODIUM CITRATE DIHYDRATE
Active strength
4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57826-460-022025-01-30C16284748780-12cef2736-63d8-d83d-e063-dadaa90ab31fHaemonetics Additive Solution Formula 3 (AS-3)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57826-460-02Haemonetics Additive Solution Formula 3 (AS-3)250 mL in 1 BAGSOLUTION2508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57826-460HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3) (CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE) SOLUTION [HAEMONETICS CORPORATION]8Legacy NDC, 1 package rows20201224_cd358c23-b653-49f8-8062-9cd5ee4dbead.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57826-460-0257826046002250 mL in 1 BAG (57826-460-02) 250 ml2013-01-100000-00-00NoNoCurrent