FDA.reportPublic FDA data

Polyethylene Glycol

Product NDC
68001-505
11-digit product format
680010505
Labeler code
68001
Product ID
68001-505_cc6e2865-14e2-1ac7-e053-2a95a90acbc0
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA091077
Marketing category
ANDA
Marketing start
2021-06-18
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P

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
68001-505-55Polyethylene Glycol238 g in 1 BOTTLEPOWDER, FOR SUSPENSION2383
68001-505-69Polyethylene Glycol510 g in 1 BOTTLEPOWDER, FOR SUSPENSION5103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-505-55GM - Gram68001-50520ea8ae2-eaa9-4fe0-b768-28dce7b448ca12021-07-15
68001-505-69GM - Gram68001-505b1fad1ea-e46d-461f-ae53-997ad411dc6c12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-505POLYETHYLENE GLYCOL POWDER, FOR SUSPENSION [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20210921_c4cae70c-68da-0bbc-e053-2a95a90a395a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-505-5568001050555238 g in 1 BOTTLE (68001-505-55) 238 g2021-06-180000-00-00NoNoCurrent
68001-505-6968001050569510 g in 1 BOTTLE (68001-505-69) 510 g2021-06-180000-00-00NoNoCurrent