Zyvit

Manufacturer
TMIG Inc.
Effective date
2017-10-24
Label type
DIETARY SUPPLEMENT
Version
6
Source
full-release
Hydrated at
2026-06-01 02:48:38

Label at a glance#

ProductZyvit
Active ingredientASCORBIC ACID, cholecalciferol, THIAMINE HYDROCHLORIDE, PYRIDOXAL PHOSPHATE ANHYDROUS, FOLIC ACID, METHYLCOBALAMIN, NADH, COENZYME Q10, (2Z)-
Label structure7 sections

Storage and handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture. KEEP OUT OF THE REACH OF CHILDREN. Tamper Evident : Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

HEALTH CLAIM:

HEALTH CLAIM SECTION

Zyvit Tablets Dietary Supplement

Dispensed by Prescription†

Supplement Facts
Serving Size: 1 Tablet

Servings per Bottle: 30

Amount Per Serving:% Daily Value
 Vitamin C (as ascorbic acid)  125 mg 208%
 Vitamin D3 (as cholecalciferol)  500 IU 125%
 Thiamin (Vitamin B1 as thiamin HCl) 25 mg 1,667%
 Vitamin B6 (as pyridoxal 5’ phosphate) 12.5 mg 625%
 Folic Acid  1 mg 250%
 Vitamin B12 (as methylcobalamin) 1 mg 16,667%
 NADH (reduced nicotinamide-adenine dinucleotide) 5 mg*
 CoEnzyme Q-10 (ubiquinone)  50 mg*
*Daily Values (DV) not established.

OTHER INGREDIENTS:  cellulose, magnesium stearate, and silicon dioxide.

DESCRIPTION:

STATEMENT OF IDENTITY SECTION

Zyvit Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

WARNING AND PRECAUTIONS

WARNINGS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Zyvit tablets should only be used under the direction and supervision of a licensed medical practitioner.  Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.


Pregnancy and Lactation
Zyvit is not intended for use in pregnant or lactating patients.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

HEALTH CLAIM SECTION

Zyvit tablets are supplied as tan, oblong shaped tablets with no imprintin a child-resistant bottle of 30ct. (69176-600-30*)

Dispensed by Prescription†

*TMIG Inc. does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx).  This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.  The ingredients, indication or claims of this product are not to be construed to be drug claims.

  1. Federal Register Notice of August 2, 1973 (38 FR 20750)
  2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

STORAGE AND HANDLING:

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Protect from heat, light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69176-600-30Zyvit30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69176-600ZYVIT (ASCORBIC ACID, CHOLECALCIFEROL, THIAMIN HCL, PYRIDOXAL 5 PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, ADENINE DINUCLEOTIDE, UBIQUINONE) TABLET [TMIG INC.]61 package rows20171025_12f1f81f-dfc5-4a23-a8ea-d3e84048a5b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69176-600-30EA - Each69176-600892338c9-9551-44d9-bdc4-0b655680b1b912017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69176-60069176-600-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

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