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  4. NDC Product Code: 70199-021 Helidac Therapy

NDC 70199-021 Helidac Therapy

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70199-021?
  5. Helidac Therapy Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 70199-021 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
70199-021
Proprietary Name:
Helidac Therapy
Product Type: [3]
Labeler Name: [5]
Casper Pharma Llc
Labeler Code:
70199
Product Label ID:
eb651905-007d-4a56-b010-db4a4f7c405d
FDA Application Number: [6]
ANDA202584
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-11-2020
End Marketing Date: [10]
06-30-2022
Listing Expiration Date: [11]
06-30-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
WHITE (C48325)
BLACK (C48323 - BLACK OPAQUE CAP)
YELLOW (C48330 - YELLOW OPAQUE BODY)
Shape:
ROUND (C48348)
CAPSULE (C48336)
Size(s):
16 MM
9 MM
22 MM
Imprint(s):
W10
3969;WPI
WPI;2235
Score:
1
Flavor(s):
WINTERGREEN (C73424)

Code Structure Chart

Product Details

What is NDC 70199-021?

The NDC code 70199-021 is assigned by the FDA to the product Helidac Therapy which is product labeled by Casper Pharma Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70199-021-14 14 blister pack in 1 carton / 4 package in 1 blister pack / 1 kit in 1 package. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Helidac Therapy?

The components of HELIDAC Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIESand DOSAGE AND ADMINISTRATION).To reduce the development of drug-resistant bacteria and maintain the effectiveness HELIDAC Therapy and other antibacterial drugs, HELIDAC Therapy should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Which are Helidac Therapy UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Helidac Therapy Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

* Please review the disclaimer below.

Patient Education

Bismuth Subsalicylate


Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.
[Learn More]


Metronidazole


Metronidazole capsules and tablets are used to treat infections of the reproductive system, gastrointestinal (GI) tract, skin, heart, bone, joint, lung, blood, nervous system, and other areas of the body. Metronidazole capsules and tablets are also used to treat sexually transmitted diseases (STDs). Metronidazole extended-release (long-acting) tablets are used to treat bacterial vaginosis (an infection caused by too much of certain types of harmful bacteria in the vagina) in women. Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


Tetracycline


Tetracycline is used to treat infections caused by bacteria including pneumonia and other respiratory tract infections; ; certain infections of skin, eye, lymphatic, intestinal, genital and urinary systems; and certain other infections that are spread by ticks, lice, mites, and infected animals. It is also used along with other medications to treat acne. Tetracycline is also used to treat plague and tuleramia (serious infections that may be spread on purpose as part of a bioterror attack). It can also be used in patients who cannot be treated with penicillin to treat certain types of food poisoning, and anthrax (a serious infection that may be spread on purpose as part of a bioterror attack). Tetracycline is in a class of medications called tetracycline antibiotics. It works by preventing the growth and spread of bacteria. Antibiotics such as tetracycline will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

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

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".