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  4. NDC Product Code: 68382-076 Acetazolamide

NDC 68382-076 Acetazolamide

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68382-076?
  4. Acetazolamide Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 68382-076 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
68382-076
Proprietary Name:
Acetazolamide
Product Type: [3]
Labeler Name: [5]
Zydus Pharmaceuticals Usa Inc.
Labeler Code:
68382
Product Label ID:
490032a5-132f-4870-90ec-6036218cbfe8
FDA Application Number: [6]
ANDA206533
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
01-09-2020
End Marketing Date: [10]
05-31-2025
Listing Expiration Date: [11]
05-31-2025
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 68382-076?

The NDC code 68382-076 is assigned by the FDA to the product Acetazolamide which is product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68382-076-10 1 vial in 1 carton / 5 ml in 1 vial. 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 Acetazolamide?

Acetazolamide is used to prevent and reduce the symptoms of altitude sickness. This medication can decrease headache, tiredness, nausea, dizziness, and shortness of breath that can occur when you climb quickly to high altitudes (generally above 10,000 feet/3,048 meters). It is particularly useful in situations when you cannot make a slow ascent. The best ways to prevent altitude sickness are climbing slowly, stopping for 24 hours during the climb to allow the body to adjust to the new height, and taking it easy the first 1 to 2 days. This medication is also used with other medications to treat high pressure inside the eye due to certain types of glaucoma. Acetazolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. It works by decreasing the production of fluid inside the eye. It is also used to decrease a buildup of body fluids (edema) caused by heart failure or certain medications. Acetazolamide can work less well over time, so it is usually used only for a short period. It has also been used with other medications to treat certain types of seizures (petit mal and unlocalized seizures).

Which are Acetazolamide UNII Codes?

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

Which are Acetazolamide 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:

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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.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, 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".