FDA.reportPublic FDA data

POLYETHYLENE GLYCOL 3350

Product NDC
17856-0489
11-digit product format
178560489
Labeler code
17856
Product ID
17856-0489_b2c5b072-befa-48fc-a2cf-08cb3a0bd6f7
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA090812
Marketing category
ANDA
Marketing start
2018-08-07
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
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
17856-0489-12020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596
17856-0489-22020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596
17856-0489-32020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596
17856-0489-42020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596
17856-0489-52020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596
17856-0489-62020-01-31C16284748780-19d75b9d0-62e0-f424-e053-dadaa90a57ceb4a571c7-230a-4955-875e-112cbe1f5596

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0489-1POLYETHYLENE GLYCOL 335017 g in 1 CUP, UNIT-DOSEPOWDER, FOR SOLUTION171
17856-0489-1POLYETHYLENE GLYCOL 335050 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION501
17856-0489-2POLYETHYLENE GLYCOL 335017 g in 1 BAGPOWDER, FOR SOLUTION171
17856-0489-2POLYETHYLENE GLYCOL 335072 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION721
17856-0489-3POLYETHYLENE GLYCOL 33504 g in 1 BAGPOWDER, FOR SOLUTION41
17856-0489-3POLYETHYLENE GLYCOL 335072 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION721
17856-0489-4POLYETHYLENE GLYCOL 335072 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION721
17856-0489-4POLYETHYLENE GLYCOL 33504.25 g in 1 BAGPOWDER, FOR SOLUTION4.251
17856-0489-5POLYETHYLENE GLYCOL 335050 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION501
17856-0489-5POLYETHYLENE GLYCOL 33508.5 g in 1 CUP, UNIT-DOSEPOWDER, FOR SOLUTION8.51
17856-0489-6POLYETHYLENE GLYCOL 33508.5 g in 1 CUP, UNIT-DOSEPOWDER, FOR SOLUTION8.51
17856-0489-6POLYETHYLENE GLYCOL 335072 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0489POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 12 package rows20180807_b4a571c7-230a-4955-875e-112cbe1f5596.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
17856-0489-11785604890117 g in 1 CUP, UNIT-DOSE17 gHistorical
17856-0489-21785604890217 g in 1 BAG17 gHistorical
17856-0489-3178560489034 g in 1 BAG4 gHistorical
17856-0489-41785604890472 in 1 BOX, UNIT-DOSEHistorical
17856-0489-51785604890550 in 1 BOX, UNIT-DOSEHistorical
17856-0489-6178560489068.5 g in 1 CUP, UNIT-DOSE8.5 gHistorical