NDC 63545-165 Arnica Montana

Arnica Montana

  1. Labeler Index
  2. Hahnemann Laboratories, Inc.
  3. NDC: 63545-165 Arnica Montana

NDC Product Code 63545-165

NDC CODE: 63545-165

Proprietary Name: Arnica Montana 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: Arnica Montana 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

NDC 63545-165-01

Package Description: 200 PELLET in 1 VIAL, GLASS

NDC 63545-165-02

Package Description: 500 PELLET in 1 VIAL, GLASS

NDC 63545-165-03

Package Description: 3000 PELLET in 1 BOTTLE, GLASS

NDC 63545-165-04

Package Description: 10000 PELLET in 1 BOTTLE, GLASS

NDC Product Information

Arnica Montana with NDC 63545-165 is a a human over the counter drug product labeled by Hahnemann Laboratories, Inc.. The generic name of Arnica Montana is arnica montana. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Hahnemann Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Arnica Montana 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.
  • ARNICA MONTANA 1 [hp_M]/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.
  • SUCROSE (UNII: C151H8M554)
  • SUCROSE (UNII: C151H8M554)

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: Hahnemann Laboratories, Inc.
Labeler Code: 63545
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: 03-12-2021 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: 12-31-2022 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 - NO 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’.

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Arnica Montana Product Label Images