FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
50090-2430
11-digit product format
500902430
Labeler code
50090
Product ID
50090-2430_0fd80f1e-8a8d-496a-92e2-20cbbed78499
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-13
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
50090-2430-02022-06-30C16284748780-19d75b9d0-1228-f424-e053-dadaa90a57cePolyethylene Glycol 3350 Drug Facts
50090-2430-02022-06-30C16284748780-19d75b9d0-1228-f424-e053-dadaa90a57cePolyethylene Glycol 3350 Drug Facts
50090-2430-02020-01-31C16284748780-19d75b9d0-1228-f424-e053-dadaa90a57cePolyethylene Glycol 3350 Drug Facts
50090-2430-02020-01-31C16284748780-19d75b9d0-1228-f424-e053-dadaa90a57cePolyethylene Glycol 3350 Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2430-0Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION23818

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2430-0GM - Gram50090-2430d79aa3b8-3482-4771-a124-ea6cf379fa2212019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2430POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 1 package rows20231211_4f31a33e-1f60-4aa7-b1dc-a3c011c03a70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2430-050090243000238 g in 1 BOTTLE (50090-2430-0) 238 g2016-07-050000-00-00NoNoCurrent