NDC 74474-102 Terravitals Midbak

Arnica Montana, Antimonium Tartaricum, Cimicifuga Racemosa, Coffea Cruda, Crotalus Horridus, Veratrum Album

NDC Product Code 74474-102

NDC CODE: 74474-102

Proprietary Name: Terravitals Midbak 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, Antimonium Tartaricum, Cimicifuga Racemosa, Coffea Cruda, Crotalus Horridus, Veratrum Album 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 - WHITE SPHEROIDS)
Size(s):
4 MM

NDC Code Structure

  • 74474 - Terravitals Llc

NDC 74474-102-01

Package Description: 1 BOTTLE, DISPENSING in 1 TUBE > 1 PELLET in 1 BOTTLE, DISPENSING

NDC Product Information

Terravitals Midbak with NDC 74474-102 is a a human over the counter drug product labeled by Terravitals Llc. The generic name of Terravitals Midbak is arnica montana, antimonium tartaricum, cimicifuga racemosa, coffea cruda, crotalus horridus, veratrum album. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Terravitals Llc

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.

Terravitals Midbak 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.

  • BLACK COHOSH 30 [hp_C]/1
  • COFFEA ARABICA FRUIT 30 [hp_C]/1
  • ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1
  • VERATRUM ALBUM ROOT 30 [hp_C]/1
  • ARNICA MONTANA WHOLE 30 [hp_C]/1
  • CROTALUS HORRIDUS HORRIDUS VENOM 6 [hp_C]/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)

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: Terravitals Llc
Labeler Code: 74474
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: 04-01-2021 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Terravitals Midbak 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

Terravitals Midbak Active Ingredients

Active ingredientsArnica montana 30C HPUSAntimonium tartaricum 30C HPUSCimicifuga racemosa 30C HPUSCoffea cruda 30C HPUSCrotalus horridus 6C HPUSVeratrum album 30C HPUSSmall inner packaging label:

Terravitals Midbak Purpose

Active ingredients** .............................…..............................….PurposeArnica montana 30C HPUS.....painful pressure middle and dorsal spineAntimonium tartaricum 30C HPUS…....... pain between shoulder bladesCimicifuga racemosa 30C HPUS............................................dorsal painCoffea cruda 30C HPUS...................pain, pressure on small of the backCrotalus horridus 6C HPUS…..................................tensive pain on backVeratrum album 30C HPUS....................pain on scapular region of back'HPUS' indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States**'C' is homeopathic dilution.Uses* For temporary relief of pain on sides of neck and nape due to minor muscle strain.**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Terravitals Warnings

Warnings Stop use and ask a doctor If symptoms persist more than 5 days or worsen. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Directions: Adults and adolescents 12 and over: Dissolve 1-2 pellets in mouth at the onset of symptoms, repeat every 1- 6 hours as needed

Terravitals Dosage

Oral soluble pellets

Terravitals Other

Other information: Store in a dry place between 15-30°C (59-86°F) and out of direct sunlight.

Otc - Do Not Use

Do not use if the seal of pellet dispenser inside is missing or broken.

Terravitals Inactive Ingredient

Inactive ingredient Organic Sucrose certified by DE-OKO-070. (Organic logo)

Terravitals Midbak Main Panel

TERRAVITALS MidBakHomeopathic MedicineRelieves middle back pain*NDC 74474-102-01Approx 75 Oral soluble pelletsNon-drowsyNot habit-formingNo drug interactionsNo known side effectsMade in the USA by Terravitals LLC, Gaithersburg MD 20879www.terravitals.comExp: MM/YYYYLot: YYADXXOuter packaging label:

* Please review the disclaimer below.