FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
45802-868
11-digit product format
458020868
Labeler code
45802
Product ID
45802-868_1a88ad2b-b557-4991-aff2-a1f96159bbdc
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
45802-868-01Polyethylene Glycol 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1199
45802-868-02Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2389
45802-868-03Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5109
45802-868-66Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION179
45802-868-66Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-868-01GM - Gram45802-86801e89a11-1621-4f8b-9e69-d1fe6184386712012-07-24
45802-868-02GM - Gram45802-8689dbdbcad-c768-42fb-97f7-67b8c0b3990c12012-07-24
45802-868-03GM - Gram45802-868fe77ce7e-35c7-4880-b241-cc9693ff2a7512012-07-24
45802-868-66EA - Each45802-868a586b756-f5eb-44f3-848c-8ad56a68247912019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [PERRIGO NEW YORK INC]3
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-868POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 5 package rows20230117_e138b8c8-48de-48cd-8baa-2cc148cef62c.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
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4f31a33e-1f60-4aa7-b1dc-a3c011c03a7018
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNe138b8c8-48de-48cd-8baa-2cc148cef62c9
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDe138b8c8-48de-48cd-8baa-2cc148cef62c9
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYe138b8c8-48de-48cd-8baa-2cc148cef62c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-868-0145802086801119 g in 1 BOTTLE (45802-868-01) 119 g2009-11-060000-00-00NoNoCurrent
45802-868-0245802086802238 g in 1 BOTTLE (45802-868-02) 238 g2009-11-040000-00-00NoNoCurrent
45802-868-0345802086803510 g in 1 BOTTLE (45802-868-03) 510 g2009-11-050000-00-00NoNoCurrent
45802-868-664580208686614 PACKET in 1 CARTON (45802-868-66) / 17 g in 1 PACKET14 packet2018-07-160000-00-00NoNoCurrent