FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
59556-762
11-digit product format
595560762
Labeler code
59556
Product ID
59556-762_27cb56bb-5999-476f-913a-e739f568bd6e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA203928
Marketing category
ANDA
Marketing start
2016-08-25
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
59556-762-00Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
59556-762-01Polyethylene Glycol 335010 in 1 CARTONPOWDER, FOR SOLUTION105
59556-762-02Polyethylene Glycol 335024 in 1 CARTONPOWDER, FOR SOLUTION245
59556-762-03Polyethylene Glycol 3350119 g in 1 CANPOWDER, FOR SOLUTION1195
59556-762-04Polyethylene Glycol 3350238 g in 1 CANPOWDER, FOR SOLUTION2385
59556-762-05Polyethylene Glycol 3350510 g in 1 CANPOWDER, FOR SOLUTION5105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-762POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [STRIDES PHARMA INC]5Current NDC, Legacy NDC, 6 package rows20220219_77b9060f-c9ab-4047-b1f1-063956678453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN77b9060f-c9ab-4047-b1f1-0639566784535
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD77b9060f-c9ab-4047-b1f1-0639566784535
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY77b9060f-c9ab-4047-b1f1-0639566784535
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN3729a1d2-4c98-dfdf-e063-6394a90a5a872
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD3729a1d2-4c98-dfdf-e063-6394a90a5a872
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY3729a1d2-4c98-dfdf-e063-6394a90a5a872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-762-005955607620017 g in 1 PACKET17 gHistorical
59556-762-015955607620110 PACKET in 1 CARTON (59556-762-01) / 17 g in 1 PACKET (59556-762-00) 10 packet2016-08-250000-00-00NoNoCurrent
59556-762-025955607620224 PACKET in 1 CARTON (59556-762-02) / 17 g in 1 PACKET (59556-762-00) 24 packet2016-08-250000-00-00NoNoCurrent
59556-762-0359556076203119 g in 1 CAN (59556-762-03) 119 g2016-08-250000-00-00NoNoCurrent
59556-762-0459556076204238 g in 1 CAN (59556-762-04) 238 g2016-08-250000-00-00NoNoCurrent
59556-762-0559556076205510 g in 1 CAN (59556-762-05) 510 g2016-08-250000-00-00NoNoCurrent