FDA.reportPublic FDA data

POLYETHYLENE GLYCOL 3350 NF

Product NDC
11534-180
11-digit product format
115340180
Labeler code
11534
Product ID
11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC
Application
ANDA206105
Marketing category
ANDA
Marketing start
2017-06-13
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 NF
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
11534-180-19POLYETHYLENE GLYCOL 3350 NF119 g in 1 BOTTLEPOWDER, FOR SOLUTION1192
11534-180-28POLYETHYLENE GLYCOL 3350 NF238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
11534-180-50POLYETHYLENE GLYCOL 3350 NF510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-180-19GM - Gram11534-18073b4d364-9253-4269-9fd3-1f5fc3aeaab012018-12-13
11534-180-28GM - Gram11534-1802718a569-b762-40d2-811b-3db3feb6fe7a12017-08-11
11534-180-50GM - Gram11534-1803d141a0c-b9a4-42c1-98aa-de9e7c90828312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-180POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SUNRISE PHARMACEUTICAL, INC]2Current NDC, Legacy NDC, 3 package rows20200123_ce5197a1-2677-4ffb-aef2-9221b28ebd23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNce5197a1-2677-4ffb-aef2-9221b28ebd232
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDce5197a1-2677-4ffb-aef2-9221b28ebd232
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYce5197a1-2677-4ffb-aef2-9221b28ebd232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-180-1911534018019119 g in 1 BOTTLE (11534-180-19) 119 g2017-06-130000-00-00NoNoCurrent
11534-180-2811534018028238 g in 1 BOTTLE (11534-180-28) 238 g2017-06-130000-00-00NoNoCurrent
11534-180-5011534018050510 g in 1 BOTTLE (11534-180-50) 510 g2017-06-130000-00-00NoNoCurrent