NDC 70556-103 Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
70556-103
Proprietary Name:
Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Ailex Pharmaceuticals, Llc
Labeler Code:
70556
Start Marketing Date: [9]
11-30-2018
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
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)

Product Packages

NDC Code 70556-103-14

Package Description: 14 BLISTER PACK in 1 CARTON / 4 PACKAGE in 1 BLISTER PACK / 1 KIT in 1 PACKAGE

Product Details

What is NDC 70556-103?

The NDC code 70556-103 is assigned by the FDA to the product Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride which is product labeled by Ailex Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70556-103-14 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 Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride?

The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (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 STUDIES and DOSAGE AND ADMINISTRATION).To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules 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 Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride UNII Codes?

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

Which are Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride 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:

What is the NDC to RxNorm Crosswalk for Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

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

[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.

[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 ("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".