NDC 68084-541 Acetazolamide
Tablet Oral

Product Information

Acetazolamide is a human prescription drug product labeled by American Health Packaging. The product's dosage form is tablet and is administered via oral form.

Product Code68084-541
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.
Acetazolamide
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.
Acetazolamide
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 - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
American Health Packaging
Labeler Code68084
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.
ANDA084840
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.
12-28-2011
End Marketing Date 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.
10-31-2022
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

What are the uses for Acetazolamide?


Product Characteristics

Color(s)WHITE (C48325 - WHITE)
ShapeROUND (C48348)
Size(s)11 MM
Imprint(s)LAN;1050
Score4

Product Packages

NDC 68084-541-01

Package Description: 10 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK (68084-541-11)

Price per Unit: $0.22879 per EA

Product Details

What are Acetazolamide Active Ingredients?

The following is the list of active ingredients in this product. 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.

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:

Inactive Ingredient(s)

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.
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CALCIUM STEARATE (UNII: 776XM7047L)

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.

Patient Education

Acetazolamide Oral

Acetazolamide Oral is pronounced as (a set a zole' a mide)

Why is acetazolamide oral medication prescribed?
Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Acetazolamide decreases the pressure in th...
[Read More]

* Please review the disclaimer below.

Acetazolamide Labeling and Warnings

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.

Table of Contents



Packaging Information



American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(250 mg / 100 UD) NDC 68084-541-01 packaged from NDC 0527-1050

Distributed by:
American Health Packaging
Columbus, OH 43217

8254101/1117


Package/Label Display Panel – Carton – 250 Mg



NDC 68084-541-01

AcetaZOLAMIDE
Tablets, USP

250 mg

100 Tablets (10 x 10)

Each Tablet Contains:
Acetazolamide, USP......................................................250 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

Rx Only

The drug product contained in this package is from
NDC # 0527-1050, Lannett Company, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

054101
0254101/0317OS


Package/Label Display Panel – Blister – 250 Mg



AcetaZOLAMIDE
Tablet, USP

250 mg


* Please review the disclaimer below.