FDA.reportPublic FDA data

Polyethylene glycol 3350

Product NDC
0904-6931
11-digit product format
009046931
Labeler code
0904
Product ID
0904-6931_d804d78d-bf7c-4ae2-a3a7-d1e7337bbeb8
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203928
Marketing category
ANDA
Marketing start
2019-06-30
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
0904-6931-26Polyethylene glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION1411
0904-6931-26Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-76Polyethylene glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION3011
0904-6931-76Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-81Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-81Polyethylene glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION10011
0904-6931-86Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6931-26EA - Each0904-693122b98f39-66d0-475e-b5bc-566b492c5f6012020-08-06
0904-6931-76EA - Each0904-6931ea58d86a-7b36-4de8-a842-48a47ffdf5c812020-03-10
0904-6931-81EA - Each0904-6931fbacfb5a-1498-4fcf-9bdf-ab1a70b8cc6d12020-04-20
0904-6931-86EA - Each0904-6931eb1bce8f-e443-42aa-a484-d8f8448a73b212020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6931POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 7 package rows20240421_ddc9d2b1-87d8-44fa-bac6-0a7261f33564.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNddc9d2b1-87d8-44fa-bac6-0a7261f3356411
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDddc9d2b1-87d8-44fa-bac6-0a7261f3356411
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYddc9d2b1-87d8-44fa-bac6-0a7261f3356411
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN2f5c975f-0d35-4f68-a27c-28af9a8987334
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4e8b6a32-11ec-4419-9ec8-aaa1823899724
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNe26457c4-03e8-430e-bfad-38ae105dbf6f4
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD2f5c975f-0d35-4f68-a27c-28af9a8987334
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4e8b6a32-11ec-4419-9ec8-aaa1823899724
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDe26457c4-03e8-430e-bfad-38ae105dbf6f4
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY2f5c975f-0d35-4f68-a27c-28af9a8987334
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4e8b6a32-11ec-4419-9ec8-aaa1823899724
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYe26457c4-03e8-430e-bfad-38ae105dbf6f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6931-260090469312614 PACKET in 1 CARTON (0904-6931-26) / 17 g in 1 PACKET14 packet2019-06-300000-00-00NoNoCurrent
0904-6931-760090469317630 PACKET in 1 CARTON (0904-6931-76) / 17 g in 1 PACKET30 packet2019-06-300000-00-00NoNoCurrent
0904-6931-8100904693181100 PACKET in 1 CARTON (0904-6931-81) / 17 g in 1 PACKET100 packet2019-06-300000-00-00NoNoCurrent
0904-6931-860090469318617 g in 1 PACKET (0904-6931-86) 17 g2019-06-300000-00-00NoNoCurrent