Folixate

Product NDC
59088-301
Requested package NDC
59088-301-54
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A9R10K3F2FInternal UNII lookup
9VU1KI44GPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671090Internal RxNorm lookup
2671097Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bb91f61-b61b-c894-e063-6394a90ae51cAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FolixateFOLATE, VITAMIN D3PureTek Corporation0bb91f61-b61b-c894-e063-6394a90ae51c2023-12-05Warnings, Adverse reactionsExact identifier
ndc (package): 59088-301-54
ndc (product): 59088-301
ndc11 (package): 59088030154

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