NDC 54868-5346 Fosinopril Sodium And Hydrochlorothiazide

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:
54868-5346
Proprietary Name:
Fosinopril Sodium And Hydrochlorothiazide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
07-06-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
I;3
Score:
1

Product Packages

NDC Code 54868-5346-0

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Code 54868-5346-1

Package Description: 10 TABLET in 1 BOTTLE, PLASTIC

Product Details

What is NDC 54868-5346?

The NDC code 54868-5346 is assigned by the FDA to the product Fosinopril Sodium And Hydrochlorothiazide which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 54868-5346-0 30 tablet in 1 bottle, plastic , 54868-5346-1 10 tablet in 1 bottle, plastic . 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 Fosinopril Sodium And Hydrochlorothiazide?

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension.These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)In using fosinopril sodium and hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema: ).

Which are Fosinopril Sodium And Hydrochlorothiazide UNII Codes?

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

Which are Fosinopril Sodium And Hydrochlorothiazide 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 Fosinopril Sodium And Hydrochlorothiazide?

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:
  • RxCUI: 857166 - fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 857166 - fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet
  • RxCUI: 857166 - FNP Sodium 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 857166 - fosinopril sodium 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 857174 - fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet

* 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.

[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".