FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
84386-125
11-digit product format
843860125
Labeler code
84386
Product ID
84386-125_0ae015fc-a1b3-4ace-b5de-85e07b154f5c
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209017
Marketing category
ANDA
Marketing start
2026-01-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene Glycol 3350
Listing expiration
2027-12-31

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
84386-125-08Polyethylene Glycol 3350119 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION1192
84386-125-14Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION172
84386-125-14Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION142
84386-125-24Polyethylene Glycol 3350238 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION2382
84386-125-54Polyethylene Glycol 3350510 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84386-125-08GM - Gram84386-1252a897776-81a9-4a9e-a660-d845d33f2a2d12026-05-22
84386-125-14EA - Each84386-12511c27e45-080e-4c13-8bc1-ba6855cccb3a12026-05-22
84386-125-24GM - Gram84386-1252c177e0a-effe-41c6-a056-bdf428233fff12026-05-22
84386-125-54GM - Gram84386-125a5568497-ef02-4465-85f2-f135fc2d36eb12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNb51f2223-8266-4d6c-bf32-58e53e73b54d2
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDb51f2223-8266-4d6c-bf32-58e53e73b54d2
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYb51f2223-8266-4d6c-bf32-58e53e73b54d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84386-125-0884386012508119 g in 1 BOTTLE, PLASTIC (84386-125-08) 119 g2026-01-07NoNoHistorical
84386-125-148438601251414 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKET14 packet2026-01-07NoNoHistorical
84386-125-2484386012524238 g in 1 BOTTLE, PLASTIC (84386-125-24) 238 g2026-01-07NoNoHistorical
84386-125-5484386012554510 g in 1 BOTTLE, PLASTIC (84386-125-54) 510 g2026-01-07NoNoHistorical