NDC 70771-1761 Bisoprolol Fumarate And Hydrochlorothiazide
Tablet, Film Coated Oral

Product Information

What is NDC 70771-1761?

The NDC code 70771-1761 is assigned by the FDA to the product Bisoprolol Fumarate And Hydrochlorothiazide which is a human prescription drug product labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 70771-1761-1 100 tablet, film coated in 1 bottle , 70771-1761-3 30 tablet, film coated in 1 bottle , 70771-1761-5 500 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70771-1761
Proprietary Name 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.		Bisoprolol Fumarate And Hydrochlorothiazide
Non-Proprietary Name 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.		Bisoprolol Fumarate And Hydrochlorothiazide
Product Type 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.		Human Prescription Drug
Dosage FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
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.		Zydus Lifesciences Limited
Labeler Code70771
FDA Application Number 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.		ANDA215666
Marketing Category 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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-01-2023
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Characteristics

Color(s)YELLOW (C48330 - WITH OCCASIONAL GREYISH TO BLACK SPECKLES)
PINK (C48328 - LIGHT PINK TO PINK)
ShapeROUND (C48348)
Size(s)7 MM
Imprint(s)113
114
Score1

Product Packages

NDC Code 70771-1761-1

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1761-3

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 70771-1761-5

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

Product Details

What are Bisoprolol Fumarate And Hydrochlorothiazide Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BISOPROLOL FUMARATE 5 mg/1 - A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS.
  • HYDROCHLOROTHIAZIDE 6.25 mg/1 - A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.

Bisoprolol Fumarate And Hydrochlorothiazide Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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: 854908 - bisoprolol fumarate 10 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet
  • RxCUI: 854908 - bisoprolol fumarate 10 MG / hydrochlorothiazide 6.25 MG Oral Tablet
  • RxCUI: 854908 - bisoprolol fumarate 10 MG / HCTZ 6.25 MG Oral Tablet
  • RxCUI: 854916 - bisoprolol fumarate 2.5 MG / hydroCHLOROthiazide 6.25 MG Oral Tablet
  • RxCUI: 854916 - bisoprolol fumarate 2.5 MG / hydrochlorothiazide 6.25 MG Oral Tablet

Bisoprolol Fumarate 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Bisoprolol Fumarate And Hydrochlorothiazide Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Package Label.Principal Display Panel



NDC 70771-1760-3

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg

30 Tablets Unit-of-Use

Rx only

2.5 mg/6.25 mg - 9d6e36f0 a9e4 4b66 997a fd5f8e4e1cf7 01

2.5 mg/6.25 mg - 9d6e36f0 a9e4 4b66 997a fd5f8e4e1cf7 01

NDC 70771-1761-3

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg

30 Tablets Unit-of-Use

Rx only

NDC 70771-1762-3

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg

30 Tablets Unit-of-Use

Rx only


* Please review the disclaimer below.