FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
63739-760
11-digit product format
637390760
Labeler code
63739
Product ID
63739-760_3516c167-5589-2050-e063-6294a90a6942
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
SKY Packaging
Application
ANDA202850
Marketing category
ANDA
Marketing start
2024-08-01
Marketing end
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene Glycol 3350

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
63739-760-01Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
63739-760-02Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION145
63739-760-03Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION305
63739-760-04Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-760POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [SKY PACKAGING]5Current NDC, 4 package rows20250515_173a62cb-9b20-4b50-e063-6294a90ac36b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN173a62cb-9b20-4b50-e063-6294a90ac36b5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD173a62cb-9b20-4b50-e063-6294a90ac36b5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY173a62cb-9b20-4b50-e063-6294a90ac36b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-760-016373907600117 g in 1 PACKET17 gHistorical
63739-760-026373907600214 PACKET in 1 CARTON (63739-760-02) / 17 g in 1 PACKET (63739-760-01) 14 packet2024-08-012026-06-30NoNoHistorical
63739-760-036373907600330 in 1 CARTONHistorical
63739-760-0463739076004100 PACKET in 1 CARTON (63739-760-04) / 17 g in 1 PACKET (63739-760-01) 100 packet2024-08-012026-09-30NoNoHistorical