FDA.reportPublic FDA data

Nicazyme Tablets Dietary Supplement

Manufacturer
Sterling Knight Pharmaceuticals LLC
Effective date
2019-06-18
Label type
Dietary Supplement
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:17

Label at a glance#

ProductNicazyme
Active ingredientNIACIN, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, COPPER, ZINC
Label structure7 sections

Dosage and administration

Usual dose is 1 to 2 tablets daily with or without food. Do not exceed 3 tablets per day.

Label contents#

Full prescribing information#

DESCRIPTION:

STATEMENT OF IDENTITY SECTION

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


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

INDICATIONS AND USAGE:

Nicazyme is indicated for patients who are deficient in, or at risk of deficiency, in, one or more of the components of the product.

CONTRAINDICATIONS:

HEALTH CLAIM SECTION

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

WARNINGS AND PRECAUTIONS:

PRECAUTIONS SECTION

This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus.

Folic acid above 1mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

Abnormal liver function test have reported in persons takings doses of 500mg or more of naicinamide.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTION:

WARNINGS SECTION

Allergic sensitization has been reported following both oral and parental administration of folic acid.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Usual dose is 1 to 2 tablets daily with or without food. Do not exceed 3 tablets per day.

STORAGE:

SAFE HANDLING WARNING SECTION

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

HOW SUPPLIED:

Nicazyme is supplied a beige tablet dispensed in white HDPE plastic bottles of 30ct.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGEBOXIMAGEBOX

Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
COPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-404-30Nicazyme30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-404NICAZYME TABLET [STERLING KNIGHT PHARMACEUTICALS LLC]11 package rows20190620_07e147a4-0766-41d2-91e1-bcc45b1f55ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-404-30EA - Each69336-404597aa386-d0eb-4508-8a7b-2641b1df9fe512019-08-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69336-40469336-404-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACIN2679MF687AACTIB
FOLIC ACID935E97BOY8ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
COPPER789U1901C5ACTIB
ZINCJ41CSQ7QDSACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiacinNIACINGolden State Medical Supply, Inc.8eff9205-84ac-e69d-e053-2995a90aad4b2026-04-15Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAvPAKdd60fe81-3d54-4a29-9502-601be89c575e2026-02-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINQUAGEN PHARMACEUTICALS LLC249e27ac-e1e7-42dc-84f6-cd32fd1d9dee2025-12-25Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINRedmont Pharmaceuticals, LLCf51f7e6d-b132-48d8-8bb1-54203472f0d82025-12-17Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINChartwell RX, LLC568c3a99-b6e8-48b4-bb68-867bbcefa0272025-12-08Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINLannett Company, Inc.d7b66e13-00ed-48a9-a54a-8e474cc31d542025-11-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAmneal Pharmaceuticals LLC7250313b-b2ef-4736-bd25-2f29c2ac0eb92025-10-03Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINMacleods Pharmaceuticals Limited52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e2025-01-10Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINSun Pharmaceutical Industries, Inc.8e290f96-e8c6-47fd-863f-1c9480f28d9b2023-11-24Warnings, Adverse reactionsName fallback
generic name: NIACIN
NIACINNIACINLupin Pharmaceuticals, Inc.92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b92023-10-06Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINAurobindo Pharma Limited43233a21-3f90-4c69-bbeb-f50d5f2d35ae2023-02-14Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacorNIACINAvondale Pharmaceuticals, LLCbf287412-160b-403f-8eb4-57f29a4759022021-12-23Warnings, Adverse reactionsName fallback
generic name: NIACIN
NiacinNIACINEmerald Therapeutics, LLC5fceeb58-e54d-43c1-8abb-33feea69d6632021-04-07Warnings, Adverse reactionsName fallback
generic name: NIACIN

Reported adverse events (FAERS/openFDA)#

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