GAVILAX

Product NDC
50090-5310
11-digit product format
500905310
Labeler code
50090
Product ID
50090-5310_9d13eb45-0bd9-4756-b8c4-7cd2b79ad5f7
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GAVILAX
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5310-02023-02-07C16284748780-1f386c649-d69d-0266-e053-dadaa90a7c1aGAVILAX
50090-5310-02023-01-30C16284748780-1f386c649-d69d-0266-e053-dadaa90a7c1aGAVILAX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5310-0GAVILAX238 g in 1 BOTTLEPOWDER, FOR SOLUTION2389

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5310-0GM - Gram50090-5310481590be-1230-4117-97d1-5b8aa41cf15d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5310GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20250110_581baa4b-7331-47a3-81c6-680286f03aca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876214GaviLAX 17 GM Powder for Oral SolutionPSN581baa4b-7331-47a3-81c6-680286f03aca9
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN581baa4b-7331-47a3-81c6-680286f03aca9
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD581baa4b-7331-47a3-81c6-680286f03aca9
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD581baa4b-7331-47a3-81c6-680286f03aca9
876214Gavilax 17 GM Powder for Oral SolutionSY581baa4b-7331-47a3-81c6-680286f03aca9
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY581baa4b-7331-47a3-81c6-680286f03aca9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5310-050090531000238 g in 1 BOTTLE (50090-5310-0) 238 g2020-10-280000-00-00NoNoCurrent