NDC 69336-349 Luvira

Luvira

NDC Product Code 69336-349

NDC 69336-349-90

Package Description: 90 CAPSULE in 1 BOTTLE

NDC Product Information

Luvira with NDC 69336-349 is a a human prescription drug product labeled by Sterling-knight Pharmaceuticals, Llc. The generic name of Luvira is luvira. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Sterling-knight Pharmaceuticals, Llc

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Luvira Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OMEGA-3 FATTY ACIDS 1220 mg/1
  • 12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- 465 mg/1
  • 4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- 375 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Fatty Acids -
  • Omega-3 - [CS]
  • Omega-3 Fatty Acid - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sterling-knight Pharmaceuticals, Llc
Labeler Code: 69336
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-17-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Luvira Product Label Images

Luvira Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Luvira is an orally administered prescription omega-3-acid 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.Luvira should be administered under the supervision of a licensed medical practitioner.SUPPLEMENT FACTSServing Size: 1 CapsuleServings Per Container:90Amount Per Serving%Daily ValueTotal Omega-3-Acid                       1220mg*Eicosapentaenoic acid (EPA)           465 mgDocosahexaenoic acid(DHA)           375 mg*Daily values not establishedOther Ingredients: Gelatin (bovine), glycerin, de-ionized water.

Indications And Usage

Luvira is an orally administered prescription probiotic 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.

Warnings And Precautions:

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

Dosage And Administration

The usual dose of Luvira is 3 - 4 capsules per day.The daily dose may be taken as a single dose of 3 - 4 capsules or 1 – 2 capsules twice daily with or without food.

How Supplied

Luvira is supplied as clear yellowish Softgel capsule dispensed in white HDPE plastic bottles of 90ct.69336-349-90

Storage And Handling

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.Reserved for Professional RecommendationAll 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, LLCRipley, MS 38663Item 34990Rev. 0620-1

* Please review the disclaimer below.