FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
62559-157
11-digit product format
625590157
Labeler code
62559
Product ID
62559-157_62f5ef8d-cbde-464f-8dd6-c087053dfd42
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA202850
Marketing category
ANDA
Marketing start
2020-03-24
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
62559-157-10Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1008
62559-157-17Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION178
62559-157-30Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-157-10EA - Each62559-157b68bdddd-f9cc-4703-bd00-3ea7d384f95d12020-04-20
62559-157-30EA - Each62559-15708831411-fd0b-47a9-bfa5-6742dde443c012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-157POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240522_1afff730-b2d3-4e01-8403-97f2ecef3a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN1afff730-b2d3-4e01-8403-97f2ecef3a748
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD1afff730-b2d3-4e01-8403-97f2ecef3a748
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY1afff730-b2d3-4e01-8403-97f2ecef3a748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-157-1062559015710100 PACKET in 1 CARTON (62559-157-10) / 17 g in 1 PACKET (62559-157-17) 100 packet2020-03-240000-00-00NoNoCurrent
62559-157-176255901571717 g in 1 PACKET17 gHistorical
62559-157-306255901573030 PACKET in 1 CARTON (62559-157-30) / 17 g in 1 PACKET (62559-157-17) 30 packet2020-03-240000-00-00NoNoCurrent