FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
72162-2172
11-digit product format
721622172
Labeler code
72162
Product ID
72162-2172_3286920b-41aa-4157-8f16-ab3aeb9dd5b9
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2172-2Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION238107
72162-2172-4Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION510107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2172-2GM - Gram72162-2172e068419a-2c21-4303-87f1-27adee56da8b12024-03-12
72162-2172-4GM - Gram72162-21722bf2c5ac-96d4-4773-9422-d55aa5e5eca312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2172POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20240203_5df518fb-ad58-4f17-af34-f66066f1313a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN5df518fb-ad58-4f17-af34-f66066f1313a107
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD5df518fb-ad58-4f17-af34-f66066f1313a107
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY5df518fb-ad58-4f17-af34-f66066f1313a107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2172-272162217202238 g in 1 BOTTLE (72162-2172-2) 238 g2024-01-23NoNoHistorical
72162-2172-472162217204510 g in 1 BOTTLE (72162-2172-4) 510 g2024-01-23NoNoHistorical