GAVILAX

Product NDC
17856-0310
11-digit product format
178560310
Labeler code
17856
Product ID
17856-0310_4c2078a3-fd70-cb56-e063-6394a90a0ff9
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA091077
Marketing category
ANDA
Marketing start
2009-10-09
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
GAVILAX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 876214

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
17856-0310-2GAVILAX72 in 1 CASEPOWDER, FOR SOLUTION721
17856-0310-2GAVILAX2 g in 1 POUCHPOWDER, FOR SOLUTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876214GaviLAX 17 GM Powder for Oral SolutionPSN4c207478-6f0f-c3cf-e063-6394a90aa4f21
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN4c207478-6f0f-c3cf-e063-6394a90aa4f21
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD4c207478-6f0f-c3cf-e063-6394a90aa4f21
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD4c207478-6f0f-c3cf-e063-6394a90aa4f21
876214Gavilax 17 GM Powder for Oral SolutionSY4c207478-6f0f-c3cf-e063-6394a90aa4f21
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY4c207478-6f0f-c3cf-e063-6394a90aa4f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0310-11785603100150 CUP, UNIT-DOSE in 1 CASE (17856-0310-1) / 2 g in 1 CUP, UNIT-DOSE2026-06-010Current
17856-0310-21785603100272 POUCH in 1 CASE (17856-0310-2) / 2 g in 1 POUCH72 pouch2026-03-03NoNoCurrent