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SPL v1

SPL

SPL Set ID 46025cb4-fe1a-5da5-e063-6294a90af293

Route

ORAL

Published

Effective Date 2025-12-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Folic Acid (1.7 mg) Cholecalciferol (0.125 mg)

Inactive Ingredients

Calcium Carbonate Stearic Acid Cellulose, Microcrystalline Calcium Phosphate, Dibasic, Dihydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Shape: oval Color: brown Size: 19 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2025-12-12

Description

Foltira is an orally administered prescription folate product.

Medication Information

Warnings and Precautions

Keep out of reach of children.

Indications and Usage

Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

Dosage and Administration

Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.

Dosage Forms and Strengths

NDC 85477-921-30

Distributed by:

Oncora Pharma

Dallas, Texas 75228

Description

Foltira is an orally administered prescription folate product.

Section 42232-9

Foltira should be administered under the supervision of a licensed medical practitioner.

Section 51945-4

Section 60561-8

Store at 20ºC - 25ºC (68º-77ºF) [See USP Controlled Room Temperature.]

Structured Label Content

Indications and Usage (34067-9)

Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

Dosage and Administration (34068-7)

Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.

Dosage Forms and Strengths (34069-5)

NDC 85477-921-30

Distributed by:

Oncora Pharma

Dallas, Texas 75228

Warnings and Precautions (34071-1)

Keep out of reach of children.

Description (34089-3)

Foltira is an orally administered prescription folate product.

Section 42232-9 (42232-9)

Foltira should be administered under the supervision of a licensed medical practitioner.

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Store at 20ºC - 25ºC (68º-77ºF) [See USP Controlled Room Temperature.]

Advanced Ingredient Data

[{"name": "FOLIC ACID", "unii": "935E97BOY8", "classCode": "ACTIB", "strengthNumerator": "1.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHOLECALCIFEROL", "unii": "1C6V77QF41", "classCode": "ACTIB", "strengthNumerator": "0.125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.", "34068-7": "Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.", "34069-5": "NDC 85477-921-30 Distributed by: Oncora Pharma Dallas, Texas 75228", "34071-1": "Keep out of reach of children.", "34089-3": "Foltira is an orally administered prescription folate product.", "42232-9": "Foltira should be administered under the supervision of a licensed medical practitioner.", "60561-8": "Store at 20ºC - 25ºC (68º-77ºF) [See USP Controlled Room Temperature.]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:12.071711 · Updated: 2026-03-14T22:39:36.817935