FDA.reportPublic FDA data

rugby PEG 3350

Product NDC
0536-1052
11-digit product format
005361052
Labeler code
0536
Product ID
0536-1052_6eba58d0-ed5a-4118-a049-c28c5dd9a4b1
Type
HUMAN OTC DRUG
Nonproprietary name
POLYETHYLENE GLYCOL 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA090685
Marketing category
ANDA
Marketing start
2015-01-05
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
rugby PEG 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
0536-1052-24rugby PEG 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2386
0536-1052-27rugby PEG 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5106
0536-1052-60rugby PEG 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1196
0536-1052-84rugby PEG 3350850 g in 1 BOTTLEPOWDER, FOR SOLUTION8506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1052-24GM - Gram0536-1052834db3b3-10f5-4d3d-a6cd-a40979f8c99512015-05-05
0536-1052-27GM - Gram0536-1052799bfc75-09a8-4b77-a130-3135914d237012015-03-03
0536-1052-60GM - Gram0536-1052922e24a6-c0a8-46ca-8623-6c574551a34f12024-11-05
0536-1052-84GM - Gram0536-1052749404ac-2510-436a-b6a3-8298e6665be912015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER [RUGBY LABORATORIES]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1052RUGBY PEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 4 package rows20240802_9c76c9b3-5203-400b-8f3a-3690bea30924.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNfb3f889c-7f88-4850-9994-d436f9010990101
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDfb3f889c-7f88-4850-9994-d436f9010990101
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYfb3f889c-7f88-4850-9994-d436f9010990101
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN9c76c9b3-5203-400b-8f3a-3690bea309246
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNf283610e-b978-4b67-b78f-e439722323176
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD9c76c9b3-5203-400b-8f3a-3690bea309246
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDf283610e-b978-4b67-b78f-e439722323176
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY9c76c9b3-5203-400b-8f3a-3690bea309246
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYf283610e-b978-4b67-b78f-e439722323176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1052-2400536105224238 g in 1 BOTTLE (0536-1052-24) 238 g2015-01-050000-00-00NoNoCurrent
0536-1052-2700536105227510 g in 1 BOTTLE (0536-1052-27) 510 g2015-01-050000-00-00NoNoCurrent
0536-1052-6000536105260119 g in 1 BOTTLE (0536-1052-60) 119 g2024-07-25NoNoHistorical
0536-1052-8400536105284850 g in 1 BOTTLE (0536-1052-84) 850 g2015-01-050000-00-00NoNoCurrent