NDC 51991-962

Polyethylene Glycol 3350

Polyethylene Glycol 3350

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

Product ID51991-962_208e9735-d53a-4a32-b4ef-09fdd37a9bdc
NDC51991-962
Product TypeHuman Otc Drug
Proprietary NamePolyethylene Glycol 3350
Generic NamePolyethylene Glycol 3350
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2019-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA090812
Labeler NameBreeckenridge Pharmaceutical, Inc.
Substance NamePOLYETHYLENE GLYCOL 3350
Active Ingredient Strength17 g/17g
Pharm ClassesOsmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51991-962-57

510 g in 1 BOTTLE (51991-962-57)
Marketing Start Date2019-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-962-57 [51991096257]

Polyethylene Glycol 3350 POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090812
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2019-03-27

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

OpenFDA Data

SPL SET ID:2b97ad05-989e-47b4-bb9a-60139c13d33b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876193

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

    NDCBrand NameGeneric Name
    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
    68071-1316Polyethylene Glycol 3350Polyethylene Glycol 3350
    71205-011Polyethylene Glycol 3350Polyethylene Glycol 3350
    14539-150POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350
    17856-0457Polyethylene Glycol 3350Polyethylene Glycol 3350
    17856-0489POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350
    35356-544Polyethylene Glycol 3350Polyethylene Glycol 3350
    45802-868Polyethylene Glycol 3350Polyethylene Glycol 3350
    50090-2430Polyethylene Glycol 3350Polyethylene Glycol 3350
    51991-961Polyethylene Glycol 3350Polyethylene Glycol 3350
    51991-457Polyethylene Glycol 3350Polyethylene Glycol 3350
    51991-962Polyethylene Glycol 3350Polyethylene Glycol 3350
    55154-6707Polyethylene Glycol 3350Polyethylene Glycol 3350
    57896-489POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350
    58602-805Polyethylene Glycol 3350Polyethylene Glycol 3350
    59556-762Polyethylene Glycol 3350Polyethylene Glycol 3350
    62175-442POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350
    62175-195Polyethylene Glycol 3350Polyethylene Glycol 3350
    63187-030Polyethylene Glycol 3350Polyethylene Glycol 3350
    60687-431Polyethylene Glycol 3350Polyethylene Glycol 3350
    57896-490Polyethylene Glycol 3350Polyethylene Glycol 3350
    53943-742Polyethylene glycol 3350Polyethylene glycol 3350
    55154-8184Polyethylene Glycol 3350Polyethylene Glycol 3350
    62559-157Polyethylene Glycol 3350Polyethylene Glycol 3350
    17856-0962Polyethylene Glycol 3350Polyethylene Glycol 3350
    55154-8091Polyethylene glycol 3350Polyethylene glycol 3350
    63629-2061Polyethylene Glycol 3350Polyethylene Glycol 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
    0904-6025peg 3350Polyethylene Glycol 3350
    0904-6422PEG 3350POLYETHYLENE GLYCOL 3350
    0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350
    0363-0306smooth laxPolyethylene Glycol 3350
    0363-0489Smooth LAXpolyethylene glycol 3350
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