FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
83324-002
11-digit product format
833240002
Labeler code
83324
Product ID
83324-002_148df422-86ec-3bae-e063-6394a90a364e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA214990
Marketing category
ANDA
Marketing start
2024-03-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-002-08Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2381
83324-002-16Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-002-08GM - Gram83324-00226ffd49f-a15c-4716-ae50-ac716322df3d12026-04-20
83324-002-16GM - Gram83324-00251957250-86ee-4b8b-938c-8bf2e9ae38fe12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-002POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION, INC.]1Current NDC, 2 package rows20240328_901a1918-87bb-47c2-a465-8c468c3a1ee5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN901a1918-87bb-47c2-a465-8c468c3a1ee51
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD901a1918-87bb-47c2-a465-8c468c3a1ee51
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY901a1918-87bb-47c2-a465-8c468c3a1ee51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-002-0883324000208238 g in 1 BOTTLE (83324-002-08) 238 g2024-03-01NoNoCurrent
83324-002-1683324000216510 g in 1 BOTTLE (83324-002-16) 510 g2024-03-01NoNoCurrent