FDA.reportPublic FDA data

Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Product NDC
21695-598
11-digit product format
216950598
Labeler code
21695
Product ID
21695-598_7546518f-b90f-477f-8f94-9ed76f98f1d7
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350, NF Powder for Solution, Laxative
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA090812
Marketing category
ANDA
Marketing start
2009-10-07
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/g
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-598-252019-09-24C16284748780-1934fe258-487b-48b1-e053-8cdaa90a720aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-598-25Polyethylene Glycol 3350, NF Powder for Solution, Laxative255 g in 1 BOTTLEPOWDER, FOR SOLUTION2551

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-598-25GM - Gram21695-598baeaf50b-6dcd-4e96-b832-6a65524e980d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1
AIRINACTIVE INGREDIENTK21NZZ5Y0BPOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-598POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110502_7546518f-b90f-477f-8f94-9ed76f98f1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN7546518f-b90f-477f-8f94-9ed76f98f1d71
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD7546518f-b90f-477f-8f94-9ed76f98f1d71
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY7546518f-b90f-477f-8f94-9ed76f98f1d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-598-2521695059825255 g in 1 BOTTLE255 gHistorical