NDC 0904-6422

PEG 3350

Polyethylene Glycol 3350

PEG 3350 is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Polyethylene Glycol 3350.

Product ID0904-6422_05f402fd-c7ac-49af-881f-7c6f6ff6ee75
NDC0904-6422
Product TypeHuman Otc Drug
Proprietary NamePEG 3350
Generic NamePolyethylene Glycol 3350
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2015-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA090685
Labeler NameMajor Pharmaceuticals
Substance NamePOLYETHYLENE GLYCOL 3350
Active Ingredient Strength17 g/17g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6422-13

510 g in 1 BOX, UNIT-DOSE (0904-6422-13)
Marketing Start Date2015-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6422-85 [00904642285]

PEG 3350 POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090685
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-10-29

NDC 0904-6422-13 [00904642213]

PEG 3350 POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090685
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-03-04

NDC 0904-6422-86 [00904642286]

PEG 3350 POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090685
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-10-29

NDC 0904-6422-81 [00904642281]

PEG 3350 POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090685
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-03-04

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

OpenFDA Data

SPL SET ID:9931bee7-7243-4b98-ac9b-a716c6db7789
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876193

    • NDC Crossover Matching brand name "PEG 3350" or generic name "Polyethylene Glycol 3350"

    NDCBrand NameGeneric Name
    0904-6025peg 3350Polyethylene Glycol 3350
    0904-6422PEG 3350POLYETHYLENE GLYCOL 3350
    50090-2526PEG 3350PEG 3350
    55154-6899PEG 3350PEG 3350
    55154-7982PEG 3350PEG 3350
    0113-7306Basic Care ClearlaxPolyethylene Glycol 3350
    0113-0306Good Sense Clear LaxPolyethylene Glycol 3350
    0113-1023good sense clearlaxPolyethylene Glycol 3350
    0113-6900injoy constipation reliefPolyethylene Glycol 3350
    0224-1890Mighty LaxPOLYETHYLENE GLYCOL 3350
    11523-4357MiraLAXPolyethylene Glycol 3350
    11523-7234MiraLAXPolyethylene Glycol 3350
    0574-0412Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350
    0722-6920Polyethylene Glycol 3350Polyethylene Glycol 3350
    0722-6921Polyethylene Glycol 3350Polyethylene Glycol 3350
    0904-6931Polyethylene glycol 3350Polyethylene glycol 3350
    10135-683Polyethylene Glycol 3350Polyethylene Glycol 3350
    0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350
    0363-0306smooth laxPolyethylene Glycol 3350
    0363-0489Smooth LAXpolyethylene glycol 3350
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