Nutricel Additive Solution - AS-3

Product NDC
53157-101
11-digit product format
531570101
Labeler code
53157
Product ID
53157-101_25edc224-0331-45f2-842d-cc2b9514a9da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CP2D/AS-3 Anticoagulant and Additive System
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Haemonetics Manufacturing Inc.
Application
BN820915
Marketing category
NDA
Marketing start
2013-09-13
Marketing end
0000-00-00
Substance
DEXTROSE; ADENINE
Active strength
1 g/110mL; g/110mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53157-101-992019-11-27C16284748780-19855d018-eace-cd31-e053-dbdaa90ab51aCP2D/AS-3 Blood Collection and Sampling System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53157-101-97Nutricel Additive Solution - AS-3110 mL in 1 BAGSOLUTION1101
53157-101-98Nutricel Additive Solution - AS-33 in 1 POUCHSOLUTION31
53157-101-99Nutricel Additive Solution - AS-38 in 1 BOXSOLUTION81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADENINEACTIVE INGREDIENTJAC85A2161NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
DEXTROSEACTIVE INGREDIENTIY9XDZ35W2NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
ADENINEACTIVE MOIETYJAC85A2161NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
DEXTROSEACTIVE MOIETYIY9XDZ35W2NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNNUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53157-101NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]1Legacy NDC, 3 package rows20140403_6ce6f3c2-bb14-4d5e-a3b1-ddaf1348e067.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53157-101-9753157010197110 mL in 1 BAG110 mlHistorical
53157-101-98531570101983 in 1 POUCHHistorical
53157-101-99531570101998 in 1 BOXHistorical