NDC 0360-0122 Chelidonium Majus

Chelidonium Maj.

NDC Product Code 0360-0122

NDC Code: 0360-0122

Proprietary Name: Chelidonium Majus 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: Chelidonium Maj. 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
5 MM

NDC Code Structure

  • 0360 - Standard Homeopathic Company
    • 0360-0122 - Chelidonium Majus

NDC 0360-0122-01

Package Description: 1 g in 1 BOTTLE, PLASTIC

NDC Product Information

Chelidonium Majus with NDC 0360-0122 is a a human over the counter drug product labeled by Standard Homeopathic Company. The generic name of Chelidonium Majus is chelidonium maj.. The product's dosage form is tablet and is administered via sublingual form.

Labeler Name: Standard Homeopathic Company

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Chelidonium Majus 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.

  • CHELIDONIUM MAJUS 30 [hp_X]/g

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.

  • ACACIA (UNII: 5C5403N26O)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Administration Route(s)

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

  • Sublingual - Administration beneath the tongue.

Product Labeler Information

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

Labeler Name: Standard Homeopathic Company
Labeler Code: 0360
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: 02-17-1997 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: 12-31-2019 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.

Chelidonium Majus Product Label Images

Chelidonium Majus 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

Indications & Usage

NAUSEA, STOMACH PAIN OR BACKACHE

Warnings

Do not use if cap band is missing or broken.If you are pregnant or nursing, consult a licensed health care professional before using this product.If symptoms persist for 7 days or worsen, contact a licensed practitioner.To be used according to label indications and/or standard homeopathic indications

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children.

Dosage & Administration

DIRECTIONS: ADULTS: Dissolve 4 tablets under tongue 4 times a day.CHILDREN: 2 tablets as above.

Inactive Ingredient

In a base of Acacia Gum and Lactose N.F.

Otc - Questions

800-624-9659

Otc - Active Ingredient

CHELIDONIUM MAJ. 30X

Otc - Purpose

NAUSEA, STOMACH PAIN OR BACKACHE

* Please review the disclaimer below.

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