57520-1493 NDC - CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, MILLEFOLIUM, SULPHURICUM ACIDUM, BELLADONNA, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, CALCAREA CARBONICA, NATRUM SULPHURICUM

Drug Information

Product NDC: 57520-1493
Proprietary Name:
Non Proprietary Name: Calendula Officinalis, Hamamelis Virginiana, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Millefolium, Sulphuricum Acidum, Belladonna, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Calcarea Carbonica, Natrum Sulphuricum
Active Ingredient(s): 12 [hp_X]/kg ACHILLEA MILLEFOLIUM WHOLE; 1 [hp_X]/kg ARNICA MONTANA WHOLE; 30 [hp_X]/kg ATROPA BELLADONNA; 12 [hp_X]/kg BELLIS PERENNIS WHOLE; 30 [hp_X]/kg CALCIUM FLUORIDE; 1 [hp_X]/kg CALENDULA OFFICINALIS FLOWERING TOP; 6 [hp_X]/kg COMFREY ROOT; 30 [hp_X]/kg FERROSOFERRIC PHOSPHATE; 1 [hp_X]/kg HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; 1 [hp_X]/kg HYPERICUM PERFORATUM WHOLE; 30 [hp_C]/kg OYSTER SHELL CALCIUM CARBONATE, CRUDE; 12 [hp_X]/kg RHODODENDRON TOMENTOSUM LEAFY TWIG; 30 [hp_X]/kg RUTA GRAVEOLENS FLOWERING TOP; 30 [hp_C]/kg SODIUM SULFATE; 12 [hp_X]/kg SULFURIC ACID; 30 [hp_X]/kg TOXICODENDRON PUBESCENS LEAF
Administration Route(s):
Dosage Form(s): LIQUID

Labeler Information

Field Name	Field Value
Labeler Name:	Apotheca Company
Product Type:	DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category:	DRUG FOR FURTHER PROCESSING
Start Marketing Date:	5/2/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	57520-1493-4	2350 kg in 1 CONTAINER (57520-1493-4)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	57520-1493	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	DRUG FOR FURTHER PROCESSING	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.
NON PROPRIETARY NAME	Calendula Officinalis, Hamamelis Virginiana, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Millefolium, Sulphuricum Acidum, Belladonna, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Calcarea Carbonica, Natrum Sulphuricum	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
START MARKETING DATE	5/2/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	DRUG FOR FURTHER PROCESSING	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.
LABELER NAME	Apotheca Company	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACHILLEA MILLEFOLIUM WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; BELLIS PERENNIS WHOLE; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF	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.
ACTIVE NUMERATOR STRENGTH	12; 1; 30; 12; 30; 1; 6; 30; 1; 1; 30; 12; 30; 30; 12; 30
ACTIVE INGRED UNIT	[hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_X]/kg; [hp_C]/kg; [hp_X]/kg; [hp_X]/kg; [hp_C]/kg; [hp_X]/kg; [hp_X]/kg

Drug Information

Labeler Information

Package Information

NDC Record

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