FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
60687-431
11-digit product format
606870431
Labeler code
60687
Product ID
60687-431_4b1bc1a8-dcf3-f253-e063-6394a90a2bb1
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203928
Marketing category
ANDA
Marketing start
2019-05-29
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
60687-431-27Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION306
60687-431-92Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1006
60687-431-98Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION146
60687-431-99Polyethylene Glycol 335017 g in 1 POUCHPOWDER, FOR SOLUTION176

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-431-27EA - Each60687-431a45e2a1e-1e0f-48ae-9277-9787532f64e812023-10-16
60687-431-92EA - Each60687-431039fb68e-505e-4c6a-a901-cff7d9792e8012020-03-10
60687-431-98EA - Each60687-431a62b1823-5483-454d-8430-eedb0677b7e312019-05-02
60687-431-99EA - Each60687-4316c1de407-c6a8-4ca1-9aca-c2c9b74340bf12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-431POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 4 package rows20241127_81374641-e54c-4b41-a3ad-49b19a097666.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN81374641-e54c-4b41-a3ad-49b19a0976666
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD81374641-e54c-4b41-a3ad-49b19a0976666
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY81374641-e54c-4b41-a3ad-49b19a0976666
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4d524ace-9de5-4f62-9263-7cd88a36b67c5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4d524ace-9de5-4f62-9263-7cd88a36b67c5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4d524ace-9de5-4f62-9263-7cd88a36b67c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-431-276068704312730 POUCH in 1 CARTON (60687-431-27) / 17 g in 1 POUCH (60687-431-99) 30 pouch2023-11-21NoNoHistorical
60687-431-9260687043192100 POUCH in 1 CARTON (60687-431-92) / 17 g in 1 POUCH (60687-431-99) 100 pouch2020-02-260000-00-00NoNoCurrent
60687-431-986068704319814 POUCH in 1 CARTON (60687-431-98) / 17 g in 1 POUCH (60687-431-99) 14 pouch2019-05-290000-00-00NoNoCurrent
60687-431-996068704319917 g in 1 POUCH17 gHistorical