Polyethylene Glycol 3350 Powder for Solution

Product NDC
76470-069
11-digit product format
764700069
Labeler code
76470
Product ID
76470-069_4223422a-0d24-f1f9-e063-6394a90ab152
Type
HUMAN OTC DRUG
Nonproprietary name
POLYETHYLENE GLYCOL, UNSPECIFIED
Dosage form
POWDER, FOR SOLUTION
Route
TOPICAL
Labeler
VALLEY MEDICAL PRODUCTS, LLC
Application
ANDA203928
Marketing category
ANDA
Marketing start
2025-10-01
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 Powder for Solution
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
76470-069-69Polyethylene Glycol 3350 Powder for Solution238 g in 1 JARPOWDER, FOR SOLUTION2381

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNae595e97-6d29-44f8-a647-fcd54fcda5b11
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDae595e97-6d29-44f8-a647-fcd54fcda5b11
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYae595e97-6d29-44f8-a647-fcd54fcda5b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76470-069-6976470006969238 g in 1 JAR (76470-069-69) 238 g2025-10-01NoNoCurrent