FDA.reportPublic FDA data

Foltira

Product NDC
85477-921
11-digit product format
854770921
Labeler code
85477
Product ID
85477-921_46025cb4-fe1b-5da5-e063-6294a90af293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folate, Vitamin D3
Dosage form
TABLET
Route
ORAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-12-12
Substance
FOLATE SODIUM; VITAMIN D
Active strength
1.7; .125 mg/1; mg/1
Pharmacologic classes
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
Foltira
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLATE SODIUM1.7 mg/1
VITAMIN D.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9P9W8GGU78Internal UNII lookup
9VU1KI44GPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1720258Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46025cb4-fe1a-5da5-e063-6294a90af293Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-921-30Foltira30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-921-30EA - Each85477-921c6851de0-1153-49a2-9f4f-08a06dd1204312026-02-05

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
FoltiraFOLATE, VITAMIN D3Oncora Pharma, LLC46025cb4-fe1a-5da5-e063-6294a90af2932025-12-15WarningsExact identifier
ndc (product): 85477-921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720258vitamin D3 125 MCG (5000 UNT) / folate 1700 MCG DFE (1000 mcg folic acid) Oral TabletPSN46025cb4-fe1a-5da5-e063-6294a90af2931
1720258cholecalciferol 5000 UNT / folic acid 1 MG Oral TabletSCD46025cb4-fe1a-5da5-e063-6294a90af2931
1720258Cholecalciferol 5000 UNT / folate 1 MG Oral TabletSY46025cb4-fe1a-5da5-e063-6294a90af2931
1720258vitamin D3 125 MCG / folic acid 1000 MCG Oral TabletSY46025cb4-fe1a-5da5-e063-6294a90af2931
1720258vitamin D3 5000 UNT / folic acid 1 MG Oral TabletSY46025cb4-fe1a-5da5-e063-6294a90af2931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-921-308547709213030 TABLET in 1 BOTTLE (85477-921-30) 30 tablet2025-12-12NoNoCurrent