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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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