FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
68001-607
11-digit product format
680010607
Labeler code
68001
Product ID
68001-607_12fe5bcd-8ad0-e159-e063-6294a90a444e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA214990
Marketing category
ANDA
Marketing start
2023-10-01
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
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
68001-607-55Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
68001-607-69Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-607-55GM - Gram68001-607a2aa048a-2c88-428f-b6ca-7e3f063216dc12023-10-16
68001-607-69GM - Gram68001-60791d8a69c-be7f-4a34-8573-08e20d88173912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-607POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20240308_02e36812-53c2-003b-e063-6394a90aed12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN02e36812-53c2-003b-e063-6394a90aed122
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD02e36812-53c2-003b-e063-6394a90aed122
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY02e36812-53c2-003b-e063-6394a90aed122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-607-5568001060755238 g in 1 BOTTLE (68001-607-55) 238 g2023-10-01NoNoCurrent
68001-607-6968001060769510 g in 1 BOTTLE (68001-607-69) 510 g2023-10-01NoNoCurrent