NDC 43857-0508 Endoplex M

Agnus Castus, Aralia Quinquefolia, Lycopodium Clavatum, Petroselinum Sativum, Sabal Serrulata, Urtica Dioica, Xanthoxylum Fraxineum, Pulsatilla (vulgaris), Glandula Suprarenalis Suis, Hypophysis Suis, Orchitinum (suis), Prostate (suis), Clematis Erecta, Juniperus Virginiana

NDC Product Code 43857-0508

NDC Code: 43857-0508

Proprietary Name: Endoplex M 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.

Non-Proprietary Name: Agnus Castus, Aralia Quinquefolia, Lycopodium Clavatum, Petroselinum Sativum, Sabal Serrulata, Urtica Dioica, Xanthoxylum Fraxineum, Pulsatilla (vulgaris), Glandula Suprarenalis Suis, Hypophysis Suis, Orchitinum (suis), Prostate (suis), Clematis Erecta, Juniperus Virginiana 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.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc
    • 43857-0508 - Endoplex M

NDC 43857-0508-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Endoplex M with NDC 43857-0508 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc. The generic name of Endoplex M is agnus castus, aralia quinquefolia, lycopodium clavatum, petroselinum sativum, sabal serrulata, urtica dioica, xanthoxylum fraxineum, pulsatilla (vulgaris), glandula suprarenalis suis, hypophysis suis, orchitinum (suis), prostate (suis), clematis erecta, juniperus virginiana. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc 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.

Endoplex M 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.

  • CHASTE TREE 3 [hp_X]/mL
  • AMERICAN GINSENG 3 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 3 [hp_X]/mL
  • PETROSELINUM CRISPUM 3 [hp_X]/mL
  • SAW PALMETTO 3 [hp_X]/mL
  • URTICA DIOICA 3 [hp_X]/mL
  • ZANTHOXYLUM AMERICANUM BARK 3 [hp_X]/mL
  • PULSATILLA VULGARIS 4 [hp_X]/mL
  • SUS SCROFA ADRENAL GLAND 6 [hp_X]/mL
  • SUS SCROFA TESTICLE 6 [hp_X]/mL
  • SUS SCROFA PITUITARY GLAND 6 [hp_X]/mL
  • SUS SCROFA PROSTATE 6 [hp_X]/mL
  • CLEMATIS RECTA FLOWERING TOP 12 [hp_X]/mL
  • JUNIPERUS VIRGINIANA TWIG 12 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.

Labeler Name: Bioactive Nutritional, Inc
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 03-18-2019 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: 12-31-2020 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.

Endoplex M Product Label Images

Endoplex M 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

Active Ingredients:

Agnus Castus 3X, Aralia Quinquefolia 3X, Lycopodium Clavatum 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Urtica Dioica 3X, Xanthoxylum Fraxineum 3X, Pulsatilla (Vulgaris) 4X, Glandula Suprarenalis Suis 6X, Hypophysis Suis 6X, Orchitinum (Suis) 6X, Prostate (Suis) 6X, Clematis Erecta 12X, Juniperus Virginiana 12X.

Indications:

For temporary relief of lowered vitality with depressed feelings, loss of nervous energy and pressure in the testicles.

For temporary relief of lowered vitality with depressed feelings, loss of nervous energy and pressure in the testicles.

Warnings:

If pregnant or breast-feeding, ask a health care 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 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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalENDOPLEX MHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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