FDA.reportPublic FDA data

POLYETHYLENE GLYCOL 3350

Product NDC
70000-0699
11-digit product format
700000699
Labeler code
70000
Product ID
70000-0699_048ca2e6-2e71-49f6-81b5-0e34a8f36b77
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
ANDA209017
Marketing category
ANDA
Marketing start
2024-11-08
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
70000-0699-1POLYETHYLENE GLYCOL 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
70000-0699-2POLYETHYLENE GLYCOL 335010 in 1 CARTONPOWDER, FOR SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0699POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [LEADER/ CARDINAL HEALTH 110, INC.]3Current NDC, 2 package rows20250317_04cc4f2e-1725-4710-8cfb-73a6bdf52e4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN04cc4f2e-1725-4710-8cfb-73a6bdf52e4f5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD04cc4f2e-1725-4710-8cfb-73a6bdf52e4f5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY04cc4f2e-1725-4710-8cfb-73a6bdf52e4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0699-17000006990117 g in 1 PACKET17 gHistorical
70000-0699-27000006990210 PACKET in 1 CARTON (70000-0699-2) / 17 g in 1 PACKET (70000-0699-1) 10 packet2024-11-08NoNoCurrent