NDC 51407-817 Duloxetine Delayed-release

Duloxetine Hydrochloride Capsule, Delayed Release Pellets Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51407-817
Proprietary Name:
Duloxetine Delayed-release
Non-Proprietary Name: [1]
Duloxetine Hydrochloride
Substance Name: [2]
Duloxetine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Code:
    51407
    FDA Application Number: [6]
    ANDA203088
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-11-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - OCHRE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    14 MM
    Imprint(s):
    B;746
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 51407-817?

    The NDC code 51407-817 is assigned by the FDA to the product Duloxetine Delayed-release which is a human prescription drug product labeled by Golden State Medical Supply, Inc.. The generic name of Duloxetine Delayed-release is duloxetine hydrochloride. The product's dosage form is capsule, delayed release pellets and is administered via oral form. The product is distributed in a single package with assigned NDC code 51407-817-60 60 capsule, delayed release pellets 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 Delayed-release?

    Duloxetine delayed-release capsules are indicated for the treatment of:Major depressive disorder in adultsGeneralized anxiety disorder in adults and pediatric patients 7 years of age and olderDiabetic peripheral neuropathic pain in adultsFibromyalgia in adultsChronic musculoskeletal pain in adultsAdditional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

    What are Duloxetine Delayed-release Active Ingredients?

    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.
    • DULOXETINE HYDROCHLORIDE 20 mg/1 - A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.

    Which are Duloxetine Delayed-release UNII Codes?

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

    Which are Duloxetine Delayed-release 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 Delayed-release?

    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

    Which are the Pharmacologic Classes for Duloxetine Delayed-release?

    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.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".