Polyethylene Glycol 3350

Product NDC
10135-683
11-digit product format
101350683
Labeler code
10135
Product ID
10135-683_d29eb471-03ff-4fee-b97e-ea68cbbe5aab
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA202071
Marketing category
ANDA
Marketing start
2019-04-01
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
NDC exclude flag
No
Listing certified through
2020-12-31
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
10135-683-042021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350
10135-683-082021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350
10135-683-122021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-683-04Polyethylene Glycol 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1192
10135-683-08Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
10135-683-12Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-683-04GM - Gram10135-683b525cf0c-7183-4e9c-9e52-a662880619d912019-06-19
10135-683-08GM - Gram10135-683fa58e979-8efc-4b73-ac89-9e629457161812019-06-19
10135-683-12GM - Gram10135-683c61bfa76-3956-44d9-83df-158d29a42dc112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-683POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 3 package rows20190518_5d2b2570-444b-4263-b339-bd81171979d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN5d2b2570-444b-4263-b339-bd81171979d62
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD5d2b2570-444b-4263-b339-bd81171979d62
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY5d2b2570-444b-4263-b339-bd81171979d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10135-683-0410135068304119 g in 1 BOTTLE119 gHistorical
10135-683-0810135068308238 g in 1 BOTTLE238 gHistorical
10135-683-1210135068312510 g in 1 BOTTLE510 gHistorical