FDA.reportPublic FDA data

Folixate

Product NDC
59088-301
11-digit product format
590880301
Labeler code
59088
Product ID
59088-301_0bb91f61-b61a-c894-e063-6394a90ae51c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folate, Vitamin D3
Dosage form
TABLET
Route
ORAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-05
Substance
LEVOMEFOLATE CALCIUM; VITAMIN D
Active strength
1000; 125 ug/1; ug/1
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMEFOLATE CALCIUM1000 ug/1
VITAMIN D125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA9R10K3F2F, 9VU1KI44GP
Rxcui2671090, 2671097

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-301-54Folixate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-301-54EA - Each59088-3011ea4bd1b-ec81-450b-b3fa-7c1c13adc0d912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-301FOLIXATE (FOLATE, VITAMIN D3) TABLET [PURETEK CORPORATION]1Current NDC, 1 package rows20231207_0bb91f61-b61b-c894-e063-6394a90ae51c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671090cholecalciferol 125 MCG (5000 UNT) / levomefolate calcium 1000 MCG Oral TabletPSN0bb91f61-b61b-c894-e063-6394a90ae51c1
2671097Folixate 125 MCG (5000 UNT) / 1000 MCG Oral TabletPSN0bb91f61-b61b-c894-e063-6394a90ae51c1
2671097cholecalciferol 0.125 MG / levomefolate calcium 1 MG Oral Tablet [Folixate]SBD0bb91f61-b61b-c894-e063-6394a90ae51c1
2671090cholecalciferol 0.125 MG / levomefolate calcium 1 MG Oral TabletSCD0bb91f61-b61b-c894-e063-6394a90ae51c1
2671090cholecalciferol 5000 UNT / levomefolate calcium 1000 MCG Oral TabletSY0bb91f61-b61b-c894-e063-6394a90ae51c1
2671097Folixate (cholecalciferol 5000 UNT / levomefolate calcium 1000 MCG) Oral TabletSY0bb91f61-b61b-c894-e063-6394a90ae51c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-301-545908803015430 TABLET in 1 BOTTLE, PLASTIC (59088-301-54) 30 tablet2023-12-05NoNoCurrent