Polyethylene Glycol-3350 and Electrolytes with Flavor Pack

Product NDC
40032-060
11-digit product format
400320060
Labeler code
40032
Product ID
40032-060_b76cfbc2-2ecf-478c-adae-a141ec93553d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polyethylene Glycol-3350 and Electrolytes with Flavor Pack
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA090186
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Active strength
240 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g
Pharmacologic classes
Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-060-192019-10-21C16284748780-1956f9ecf-de4e-621f-e053-dbdaa90a74adPEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-060-19Polyethylene Glycol-3350 and Electrolytes with Flavor Pack278.26 g in 1 BOTTLEPOWDER, FOR SOLUTION278.262

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM SULFATE ANHYDROUSACTIVE INGREDIENT36KCS0R750POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SULFATE IONACTIVE MOIETY7IS9N8KPMGPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-060POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2Legacy NDC, 1 package rows20091119_bf8925e7-6ea6-448c-810d-6f0d99127896.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966914polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 227.41 GM Powder for Oral SolutionPSNbf8925e7-6ea6-448c-810d-6f0d991278962
966914polyethylene glycol 3350 240000 MG / potassium chloride 2980 MG / sodium bicarbonate 6720 MG / sodium chloride 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSCDbf8925e7-6ea6-448c-810d-6f0d991278962
966914polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 227.41 GM Powder for Oral SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962
966914POLYETHYLENE GLYCOL 3350 240000 MG / K+ Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962
966914POLYETHYLENE GLYCOL 3350 240000 MG / Pot Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40032-060-1940032006019278.26 g in 1 BOTTLE278.26 gHistorical