NDC 61919-542

GAVILAX

Gavilax

GAVILAX is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Polyethylene Glycol 3350.

Product ID61919-542_267d6042-f4cc-4d5c-e054-00144ff8d46c
NDC61919-542
Product TypeHuman Prescription Drug
Proprietary NameGAVILAX
Generic NameGavilax
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA091077
Labeler NameDirectRX
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-542-51

510 g in 1 BOTTLE (61919-542-51)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-542-51 [61919054251]

GAVILAX POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091077
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

OpenFDA Data

SPL SET ID:267de1ce-baa2-5a0b-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876193

    • Pharmacological Class

    • Osmotic Activity [MoA]
    • Osmotic Laxative [EPC]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

    NDC Crossover Matching brand name "GAVILAX" or generic name "Gavilax"

    NDCBrand NameGeneric Name
    17856-0312GAVILAXPolyethylene Glycol 3350
    43386-312GAVILAXPolyethylene Glycol 3350
    50090-5310GAVILAXPolyethylene Glycol 3350
    61919-542GAVILAXGAVILAX
    63187-368GAVILAXPolyethylene Glycol 3350
    68788-7508GAVILAXPolyethylene Glycol 3350
    68788-9849GAVILAXPolyethylene Glycol 3350
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