Benazepril Hydrochloride And Hydrochlorothiazide
NDC 54868-5256

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-5256?
  5. Benazepril Hydrochloride And Hydrochlorothiazide Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Benazepril Hydrochloride And Hydrochlorothiazide is a ANDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a pink product. This product entry covers the primary NDC 54868-5256 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-5256
Proprietary Name:
Benazepril Hydrochloride And Hydrochlorothiazide
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
abc87aa0-77f3-441e-96a5-0f0bc4e8afd0
FDA Application Number: [6]
ANDA076631
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-24-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
PINK (C48328)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
E204
Score:
2

Code Structure Chart

Product Details

What is NDC 54868-5256?

The NDC code 54868-5256 is assigned by the FDA to the product Benazepril Hydrochloride And Hydrochlorothiazide. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-5256-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension.This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).In using benazepril hydrochloride 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 benazepril does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis).Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 898362 - benazepril HCl 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 898362 - benazepril hydrochloride 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet
  • RxCUI: 898362 - benazepril hydrochloride 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 898362 - BZP hydrochloride 10 MG / HCTZ 12.5 MG Oral Tablet
  • RxCUI: 898367 - benazepril HCl 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".