Polyethylene Glycol (3350)

Product NDC
51079-306
11-digit product format
510790306
Labeler code
51079
Product ID
51079-306_e67ef7f0-6cb2-4f99-b29c-e4f122e2e250
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol (3350)
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA078915
Marketing category
ANDA
Marketing start
2009-10-12
Substance
POLYETHYLENE GLYCOL 3500
Active strength
17 g/17g
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 350017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFVS1AZD90Y
Rxcui876193

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-306-01Polyethylene Glycol (3350)17 g in 1 POUCHPOWDER, FOR SOLUTION1716
51079-306-30Polyethylene Glycol (3350)30 in 1 CARTONPOWDER, FOR SOLUTION3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-306-01EA - Each51079-3066edd47d6-585c-4aec-9825-167d6c26d04812012-07-24
51079-306-30EA - Each51079-30664c4049d-cf71-4b4d-85d3-81506f8bc6f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3500ACTIVE INGREDIENTFVS1AZD90YPOLYETHYLENE GLYCOL (3350) POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOL 3500ACTIVE MOIETYFVS1AZD90YPOLYETHYLENE GLYCOL (3350) POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-306POLYETHYLENE GLYCOL (3350) POWDER, FOR SOLUTION [MYLAN INSTITUTIONAL INC.]15Current NDC, Legacy NDC, 2 package rows20240718_219bcbc4-b84a-4209-9f34-ef2b0ef0d273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN219bcbc4-b84a-4209-9f34-ef2b0ef0d27316
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD219bcbc4-b84a-4209-9f34-ef2b0ef0d27316
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY219bcbc4-b84a-4209-9f34-ef2b0ef0d27316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-306-015107903060117 g in 1 POUCH17 gHistorical
51079-306-305107903063030 POUCH in 1 CARTON (51079-306-30) / 17 g in 1 POUCH (51079-306-01) 30 pouch2009-10-120000-00-00NoNoCurrent