NDC 57520-0603 Colic

Beta Vulgaris, Carduus Marianus, Lappa Major, Aluminium Metallicum, Arsenicum Album, Chelidonium Majus, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus,

NDC Product Code 57520-0603

NDC Code: 57520-0603

Proprietary Name: Colic 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: Beta Vulgaris, Carduus Marianus, Lappa Major, Aluminium Metallicum, Arsenicum Album, Chelidonium Majus, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, 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

  • 57520 - Apotheca Company
    • 57520-0603 - Colic

NDC 57520-0603-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Colic with NDC 57520-0603 is a a human over the counter drug product labeled by Apotheca Company. The generic name of Colic is beta vulgaris, carduus marianus, lappa major, aluminium metallicum, arsenicum album, chelidonium majus, hydrastis canadensis, lycopodium clavatum, natrum sulphuricum, nux vomica, phosphorus,. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Apotheca Company

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.

Colic 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.

  • BETA VULGARIS 3 [hp_X]/mL
  • SILYBUM MARIANUM SEED 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • ALUMINUM 12 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • CHELIDONIUM MAJUS 12 [hp_X]/mL
  • GOLDENSEAL 12 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/mL
  • SODIUM SULFATE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL

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: Apotheca Company
Labeler Code: 57520
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: 01-28-2011 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: 12-31-2018 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: E 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.

Previous Code
57520-0598
Next Code
57520-0604