Roflumilast
NDC 64380-786

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64380-786?
  5. Roflumilast Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

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

Roflumilast is a ANDA-approved product labeled by Strides Pharma Science Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 64380-786 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64380-786
Proprietary Name:
Roflumilast
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Strides Pharma Science Limited
Labeler Code:
64380
Product Label ID:
78d2644d-b62c-48f5-8407-2adf09bcb144
FDA Application Number: [6]
ANDA208247
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-13-2022
End Marketing Date: [10]
09-08-2026
Listing Expiration Date: [11]
09-08-2026
Exclude Flag: [12]
D

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
05;R
Score:
1

Code Structure Chart

Product Details

What is NDC 64380-786?

The NDC code 64380-786 is assigned by the FDA to the product Roflumilast. This pharmaceutical product is labeled by Strides Pharma Science Limited and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 64380-786-01, 64380-786-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of UseRoflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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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Patient Education

Roflumilast


Roflumilast is used in people with severe chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) to reduce the number of episodes or worsening of COPD symptoms. Roflumilast is in a class of medications called phosphodiesterase inhibitors. It works by decreasing swelling in the lungs.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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.
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".