1. Home
  2. Labeler Index
  3. Cadila Healthcare Limited
  4. NDC Product Code: 65841-776 Duloxetine

NDC 65841-776 Duloxetine

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65841-776?
  5. Duloxetine Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
65841-776
Proprietary Name:
Duloxetine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Cadila Healthcare Limited
Labeler Code:
65841
Product Label ID:
5e7fad97-2e62-4f1c-92aa-ea1318c3db09
Start Marketing Date: [9]
02-15-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - GREEN)
WHITE (C48325 - WHITE)
BLUE (C48333 - BLUE)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
16 MM
19 MM
Imprint(s):
241;20;MG
242;30;MG
243;60;MG
Score:
1

Product Packages

NDC Code 65841-776-06

Package Description: 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC Code 65841-776-10

Package Description: 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE

NDC Code 65841-776-16

Package Description: 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Product Details

What is NDC 65841-776?

The NDC code 65841-776 is assigned by the FDA to the product Duloxetine which is product labeled by Cadila Healthcare Limited. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 65841-776-06 30 capsule, delayed release in 1 bottle , 65841-776-10 1000 capsule, delayed release in 1 bottle , 65841-776-16 90 capsule, delayed release 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 Duloxetine?

Duloxetine delayed-release capsules, USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short term and one maintenance trial in adults [see CLINICAL STUDIES (14.1)].  A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

Which are Duloxetine UNII Codes?

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

Which are Duloxetine 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:

What is the NDC to RxNorm Crosswalk for Duloxetine?

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: 596926 - DULoxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule

* Please review the disclaimer below.

Product Footnotes

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

[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".