FDA.reportPublic FDA data

POLYETHYLENE GLYCOL 3350

Product NDC
57896-489
11-digit product format
578960489
Labeler code
57896
Product ID
57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
ANDA090812
Marketing category
ANDA
Marketing start
2014-05-01
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POLYETHYLENE GLYCOL 3350
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193

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
57896-489-142020-12-22C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-302020-12-22C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-142020-01-31C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489
57896-489-302020-01-31C16284748780-19d75b9d1-1edb-f424-e053-dadaa90a57cegc peg 489

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-489-14POLYETHYLENE GLYCOL 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2385
57896-489-30POLYETHYLENE GLYCOL 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-489-14GM - Gram57896-48911727b7b-d1a3-4e22-8351-feb7b914446112013-03-03
57896-489-30GM - Gram57896-489a2e5e091-af1d-45aa-8b51-91e858afac4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-489POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20221125_f4c7eb80-d8d5-406d-90d0-9d17914d71f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY66276671-0ccd-4c32-a697-31e679fce0e3102
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYf4c7eb80-d8d5-406d-90d0-9d17914d71f25
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNb4a571c7-230a-4955-875e-112cbe1f55961
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDb4a571c7-230a-4955-875e-112cbe1f55961
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYb4a571c7-230a-4955-875e-112cbe1f55961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-489-1457896048914238 g in 1 BOTTLE (57896-489-14) 238 g2016-07-010000-00-00NoNoCurrent
57896-489-3057896048930510 g in 1 BOTTLE (57896-489-30) 510 g2016-07-010000-00-00NoNoCurrent