FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
57896-490
11-digit product format
578960490
Labeler code
57896
Product ID
57896-490_f0c44850-fe07-4c48-bb9c-ded2c7fb822b
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Gericare Pharmaceuticals
Application
ANDA203928
Marketing category
ANDA
Marketing start
2022-10-27
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
57896-490-01Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
57896-490-03Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION305
57896-490-07Polyethylene Glycol 3350119 g in 1 CANPOWDER, FOR SOLUTION1195
57896-490-14Polyethylene Glycol 3350238 g in 1 CANPOWDER, FOR SOLUTION2385
57896-490-30Polyethylene Glycol 3350510 g in 1 CANPOWDER, FOR SOLUTION5105
57896-490-45Polyethylene Glycol 3350765 g in 1 CANPOWDER, FOR SOLUTION7655

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-490-01EA - Each57896-490ede5bbcf-1589-40bf-a1b7-fe5092aaf06412023-06-06
57896-490-03EA - Each57896-490fa65e357-a4c0-4189-8032-3c4329957a5312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-490POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERICARE PHARMACEUTICALS]5Current NDC, Legacy NDC, 6 package rows20221029_5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-490-015789604900117 g in 1 PACKET17 gHistorical
57896-490-035789604900330 PACKET in 1 CARTON (57896-490-03) / 17 g in 1 PACKET (57896-490-01) 30 packet2022-10-270000-00-00NoNoCurrent
57896-490-0757896049007119 g in 1 CAN (57896-490-07) 119 g2022-10-270000-00-00NoNoCurrent
57896-490-1457896049014238 g in 1 CAN (57896-490-14) 238 g2022-10-270000-00-00NoNoCurrent
57896-490-3057896049030510 g in 1 CAN (57896-490-30) 510 g2022-10-270000-00-00NoNoCurrent
57896-490-4557896049045765 g in 1 CAN (57896-490-45) 765 g2022-10-270000-00-00NoNoCurrent