FDA.reportPublic FDA data

Polyethylene Gycol 3350

Product NDC
69168-473
11-digit product format
691680473
Labeler code
69168
Product ID
69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Gycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Allegiant Health
Application
ANDA214990
Marketing category
ANDA
Marketing start
2025-03-17
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/g
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 Gycol 3350
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/g

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
69168-473-55Polyethylene Gycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5101
69168-473-56Polyethylene Gycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2381
69168-473-61Polyethylene Gycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2381
69168-473-62Polyethylene Gycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-473POLYETHYLENE GYCOL 3350 POWDER, FOR SOLUTION [ALLEGIANT HEALTH]1Current NDC, 4 package rows20250321_13851c9a-a226-481b-9db5-bc7053997df7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN13851c9a-a226-481b-9db5-bc7053997df71
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD13851c9a-a226-481b-9db5-bc7053997df71
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY13851c9a-a226-481b-9db5-bc7053997df71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-473-5569168047355510 g in 1 BOTTLE (69168-473-55) 510 g2025-03-17NoNoHistorical
69168-473-5669168047356238 g in 1 BOTTLE (69168-473-56) 238 g2025-03-17NoNoHistorical
69168-473-6169168047361238 g in 1 BOTTLE (69168-473-61) 238 g2025-03-17NoNoHistorical
69168-473-6269168047362510 g in 1 BOTTLE (69168-473-62) 510 g2025-03-17NoNoHistorical