FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
17856-0457
11-digit product format
178560457
Labeler code
17856
Product ID
17856-0457_a5b0cdae-34c4-4db6-b625-42c7b8844607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA077706
Marketing category
ANDA
Marketing start
2006-09-06
Marketing end
0000-00-00
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
2019-12-31
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
17856-0457-12020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution
17856-0457-22020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution
17856-0457-32020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution
17856-0457-42020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution
17856-0457-52020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution
17856-0457-62020-01-31C16284748780-19d75b9d0-d642-f424-e053-dadaa90a57cePolyethylene Glycol 3350 NF Polyethylene Glycol 3350 Powder for Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0457-1Polyethylene Glycol 335017 g in 1 CUPPOWDER, FOR SOLUTION172
17856-0457-1Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-2Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-2Polyethylene Glycol 335017 g in 1 POUCHPOWDER, FOR SOLUTION172
17856-0457-3Polyethylene Glycol 33504 g in 1 POUCHPOWDER, FOR SOLUTION42
17856-0457-3Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-4Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-4Polyethylene Glycol 33504.25 g in 1 POUCHPOWDER, FOR SOLUTION4.252
17856-0457-5Polyethylene Glycol 33508.5 g in 1 CUPPOWDER, FOR SOLUTION8.52
17856-0457-5Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-6Polyethylene Glycol 335072 in 1 CASEPOWDER, FOR SOLUTION722
17856-0457-6Polyethylene Glycol 33508.5 g in 1 POUCHPOWDER, FOR SOLUTION8.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0457POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 12 package rows20180605_ef00202d-7a97-43df-adc7-c4043b54df03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNef00202d-7a97-43df-adc7-c4043b54df032
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDef00202d-7a97-43df-adc7-c4043b54df032
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYef00202d-7a97-43df-adc7-c4043b54df032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0457-11785604570117 g in 1 CUP17 gHistorical
17856-0457-21785604570272 in 1 CASEHistorical
17856-0457-3178560457034 g in 1 POUCH4 gHistorical
17856-0457-41785604570472 in 1 CASEHistorical
17856-0457-5178560457058.5 g in 1 CUP8.5 gHistorical
17856-0457-61785604570672 in 1 CASEHistorical