NDC 52427-672 Sertraline Hcl
Sertraline Hydrochloride Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 52427 - Almatica Pharma Llc
- 52427-672 - Sertraline Hcl
Product Characteristics
WHITE (C48325)
GREEN (C48329 - YELLOWISH GREEN)
19 MM
ALM;672
Product Packages
Product Details
What is NDC 52427-672?
What are the uses for Sertraline Hcl?
What are Sertraline Hcl Active Ingredients?
- SERTRALINE HYDROCHLORIDE 200 mg/1 - A selective serotonin uptake inhibitor that is used in the treatment of depression.
Which are Sertraline Hcl UNII Codes?
The UNII codes for the active ingredients in this product are:
- SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X)
- SERTRALINE (UNII: QUC7NX6WMB) (Active Moiety)
Which are Sertraline Hcl 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:
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
What is the NDC to RxNorm Crosswalk for Sertraline Hcl?
- RxCUI: 251201 - sertraline 200 MG Oral Capsule
- RxCUI: 410584 - sertraline 150 MG Oral Capsule
Which are the Pharmacologic Classes for Sertraline Hcl?
* Please review the disclaimer below.
Patient Education
Sertraline
Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.
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* Please review the disclaimer below.
[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".