FDA.reportPublic FDA data

GAVILAX

Product NDC
43386-312
11-digit product format
433860312
Labeler code
43386
Product ID
43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-312-07GAVILAX119 g in 1 BOTTLEPOWDER, FOR SOLUTION1198
43386-312-08GAVILAX238 g in 1 BOTTLEPOWDER, FOR SOLUTION2388
43386-312-14GAVILAX510 g in 1 BOTTLEPOWDER, FOR SOLUTION5108
43386-312-85GAVILAX850 g in 1 BOTTLEPOWDER, FOR SOLUTION8508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-312-08GM - Gram43386-31257798290-79a3-4b31-81dc-ba4a8f41a9db12012-07-24
43386-312-14GM - Gram43386-3128ab2f632-0a16-4655-9b64-514a838fe0e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PGAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]2
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PGAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-312GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20240131_19672e23-1606-497e-a112-939af33af195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876214GaviLAX 17 GM Powder for Oral SolutionPSNc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBDc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876214Gavilax 17 GM Powder for Oral SolutionSYc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
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
876214GaviLAX 17 GM Powder for Oral SolutionPSN19672e23-1606-497e-a112-939af33af1958
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN19672e23-1606-497e-a112-939af33af1958
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD19672e23-1606-497e-a112-939af33af1958
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD19672e23-1606-497e-a112-939af33af1958
876214Gavilax 17 GM Powder for Oral SolutionSY19672e23-1606-497e-a112-939af33af1958
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY19672e23-1606-497e-a112-939af33af1958
876214GaviLAX 17 GM Powder for Oral SolutionPSN21654def-5ae0-422d-961b-1fe2456af00a7
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN21654def-5ae0-422d-961b-1fe2456af00a7
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD21654def-5ae0-422d-961b-1fe2456af00a7
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD21654def-5ae0-422d-961b-1fe2456af00a7
876214Gavilax 17 GM Powder for Oral SolutionSY21654def-5ae0-422d-961b-1fe2456af00a7
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY21654def-5ae0-422d-961b-1fe2456af00a7
876214GaviLAX 17 GM Powder for Oral SolutionPSN199d6173-3fad-49e4-88fe-bde7223ed4c36
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN199d6173-3fad-49e4-88fe-bde7223ed4c36
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBD199d6173-3fad-49e4-88fe-bde7223ed4c36
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD199d6173-3fad-49e4-88fe-bde7223ed4c36
876214Gavilax 17 GM Powder for Oral SolutionSY199d6173-3fad-49e4-88fe-bde7223ed4c36
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY199d6173-3fad-49e4-88fe-bde7223ed4c36
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 startMarketing endSampleExclude flagStatus
43386-312-0743386031207119 g in 1 BOTTLE (43386-312-07) 119 g2009-10-090000-00-00NoNoCurrent
43386-312-0843386031208238 g in 1 BOTTLE (43386-312-08) 238 g2009-10-090000-00-00YesNoCurrent
43386-312-1443386031214510 g in 1 BOTTLE (43386-312-14) 510 g2009-10-090000-00-00YesNoCurrent
43386-312-8543386031285850 g in 1 BOTTLE (43386-312-85) 850 g2009-10-090000-00-00NoNoCurrent