NDC 80814-0001 Transform 30
Fucus Vesiculosus, Cysteinum, Nicotinamidum, Alpha-lipoicum Acidum, Antimonium Crudum,...

Product Information

What is NDC 80814-0001?

The NDC code 80814-0001 is assigned by the FDA to the product Transform 30 which is a human over the counter drug product labeled by H2 Nutrition. The generic name of Transform 30 is fucus vesiculosus, cysteinum, nicotinamidum, alpha-lipoicum acidum, antimonium crudum, chromium sulphuricum, gambogia, anacardium orientale, graphites. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 80814-0001-1 60 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code80814-0001
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Transform 30
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Fucus Vesiculosus, Cysteinum, Nicotinamidum, Alpha-lipoicum Acidum, Antimonium Crudum, Chromium Sulphuricum, Gambogia, Anacardium Orientale, Graphites
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
H2 Nutrition
Labeler Code80814
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-07-2021
Listing Expiration Date 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.
12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Transform 30?


Product Packages

NDC Code 80814-0001-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

Product Details

What are Transform 30 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ALPHA LIPOIC ACID 12 [hp_X]/mL - An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS.
  • ANTIMONY TRISULFIDE 12 [hp_X]/mL
  • CHROMIC SULFATE PENTADECAHYDRATE 12 [hp_X]/mL
  • CYSTEINE 6 [hp_X]/mL - A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.
  • FUCUS VESICULOSUS 3 [hp_X]/mL - A genus of BROWN ALGAE in the family Fucaceae. It is found in temperate, marine intertidal areas along rocky coasts and is a source of ALGINATES. Some species of Fucus are referred to as KELP.
  • GAMBOGE 12 [hp_X]/mL - A plant genus of the family CLUSIACEAE. Members contain XANTHONES.
  • GRAPHITE 30 [hp_C]/mL - An allotropic form of carbon that is used in pencils, as a lubricant, and in matches and explosives. It is obtained by mining and its dust can cause lung irritation.
  • NIACINAMIDE 6 [hp_X]/mL - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
  • SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/mL

Transform 30 Active Ingredients UNII Codes

Transform 30 Inactive Ingredients UNII Codes

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.

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Transform 30 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients:



Fucus Vesiculosus 3X, Cysteinum 6X, Nicotinamidum 6X, Alpha-Lipoicum Acidum 12X, Antimonium Crudum 12X, Chromium Sulphuricum 12X, Gambogia 12X, Anacardium Orientale 30C, Graphites 30C.


Indications:



May temporarily relieve symptoms when reducing diet intake such as food cravings, excessive appetite, regulation of metabolism and fatigue.

May temporarily relieve symptoms when reducing diet intake such as food cravings, excessive appetite, regulation of metabolism and fatigue.


Warnings:



If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.


Keep Out Of Reach Of Children:



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions:



Adults 8-10 drops orally, 3 times daily or as otherwise directed by a health care professional.


Inactive Ingredients:



American Ginseng (root) Panax Quinquefolius, Demineralized Water, 25% Ethanol, Green Tea (leaf) Camellia Sinensis, Garcinia (fruit) Garcinia Cambogia, Guarana (seed) Paullinia Cupana, Maca (root) Lepidium Meyenii, Forskohlii (root) Plectranthus Barbatus, Guggul (resin) Commiphora Mukul


Questions:



Dist. by: H2 Nutrition

14 South Baltic Pl.

Meridian, ID 83642

drmicronutrition.com


Package Label Display:



TRANSFORM

30

HOMEOPATHIC 

2 fl. oz. (60 ml)


* Please review the disclaimer below.