NDC 42571-141 Dorzolamide Hydrochloride Ophthalmic Solution

Dorzolamide Hydrochloride

NDC Product Code 42571-141

NDC CODE: 42571-141

Proprietary Name: Dorzolamide Hydrochloride Ophthalmic Solution 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.

Non-Proprietary Name: Dorzolamide Hydrochloride 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.

NDC Code Structure

  • 42571 - Micro Labs Limited
    • 42571-141 - Dorzolamide Hydrochloride Ophthalmic Solution

NDC 42571-141-26

Package Description: 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE

NDC Product Information

Dorzolamide Hydrochloride Ophthalmic Solution with NDC 42571-141 is a a human prescription drug product labeled by Micro Labs Limited. The generic name of Dorzolamide Hydrochloride Ophthalmic Solution is dorzolamide hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Micro Labs Limited

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug 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.

Dorzolamide Hydrochloride Ophthalmic Solution Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DORZOLAMIDE HYDROCHLORIDE 20 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Carbonic Anhydrase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Carbonic Anhydrase Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Micro Labs Limited
Labeler Code: 42571
FDA Application Number: ANDA204778 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 11-11-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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