FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
58602-805
11-digit product format
586020805
Labeler code
58602
Product ID
58602-805_af3011d1-9e74-42f2-bbc8-8f08c45898ea
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA209017
Marketing category
ANDA
Marketing start
2018-04-09
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
58602-805-01Polyethylene Glycol 3350119 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION1199
58602-805-02Polyethylene Glycol 3350238 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION2389
58602-805-03Polyethylene Glycol 3350510 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION5109
58602-805-04Polyethylene Glycol 3350850 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION8509
58602-805-25Polyethylene Glycol 3350765 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION7659
58602-805-27Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION149
58602-805-27Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION179

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-805-01GM - Gram58602-805bd24f2da-2166-4913-9df7-578133273bb312026-02-05
58602-805-02GM - Gram58602-8054360bb71-2e9b-4227-a40d-63e3d70c99e812026-02-05
58602-805-03GM - Gram58602-805d36efcb9-552e-41d6-9ec5-959ef1f324d112026-02-05
58602-805-27EA - Each58602-805f2ce425f-025f-4c82-8484-e5c367b8c19212026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-805POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [AUROHEALTH LLC]7Current NDC, Legacy NDC, 7 package rows20250515_d3c77f3f-57aa-4e2d-88aa-731cbb22af70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNd3c77f3f-57aa-4e2d-88aa-731cbb22af709
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDd3c77f3f-57aa-4e2d-88aa-731cbb22af709
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYd3c77f3f-57aa-4e2d-88aa-731cbb22af709

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-805-0158602080501119 g in 1 BOTTLE, PLASTIC (58602-805-01) 119 g2018-04-090000-00-00NoNoCurrent
58602-805-0258602080502238 g in 1 BOTTLE, PLASTIC (58602-805-02) 238 g2018-04-090000-00-00NoNoCurrent
58602-805-0358602080503510 g in 1 BOTTLE, PLASTIC (58602-805-03) 510 g2018-04-090000-00-00NoNoCurrent
58602-805-0458602080504850 g in 1 BOTTLE, PLASTIC (58602-805-04) 850 g2018-04-090000-00-00NoNoCurrent
58602-805-2558602080525765 g in 1 BOTTLE, PLASTIC (58602-805-25) 765 g2024-04-23NoNoHistorical
58602-805-275860208052714 PACKET in 1 CARTON (58602-805-27) / 17 g in 1 PACKET14 packet2024-04-23NoNoHistorical