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NDC 71288-033 Ampicillin And Sulbactam

Ampicillin Sodium And Sulbactam Sodium Injection, Powder, For Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71288-033?
  4. Ampicillin And Sulbactam Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

NDC Product Code:
71288-033
Proprietary Name:
Ampicillin And Sulbactam
Non-Proprietary Name: [1]
Ampicillin Sodium And Sulbactam Sodium
Substance Name: [2]
Ampicillin Sodium; Sulbactam Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Meitheal Pharmaceuticals Inc.
    Labeler Code:
    71288
    Product Label ID:
    139b4b2e-46f7-44a8-9cc1-774afa463b80
    FDA Application Number: [6]
    ANDA065314
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    11-27-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 71288-033?

    The NDC code 71288-033 is assigned by the FDA to the product Ampicillin And Sulbactam which is a human prescription drug product labeled by Meitheal Pharmaceuticals Inc.. The generic name of Ampicillin And Sulbactam is ampicillin sodium and sulbactam sodium. The product's dosage form is injection, powder, for solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 71288-033-75 1 bottle in 1 carton / 1 injection, powder, for solution 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 and RxNorm crosswalk.

    What are the uses for Ampicillin And Sulbactam?

    Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

    What are Ampicillin And Sulbactam 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.
    • AMPICILLIN SODIUM 10 g/1 - Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.
    • SULBACTAM SODIUM 5 g/1 - A beta-lactamase inhibitor with very weak antibacterial action. The compound prevents antibiotic destruction of beta-lactam antibiotics by inhibiting beta-lactamases, thus extending their spectrum activity. Combinations of sulbactam with beta-lactam antibiotics have been used successfully for the therapy of infections caused by organisms resistant to the antibiotic alone.

    Which are Ampicillin And Sulbactam UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Ampicillin And Sulbactam?

    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: 240984 - ampicillin 100 MG / sulbactam 50 MG per ML Injectable Solution
    • RxCUI: 240984 - ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution
    • RxCUI: 240984 - ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution
    • RxCUI: 240984 - ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable Solution

    Which are the Pharmacologic Classes for Ampicillin And Sulbactam?

    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.

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    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".