NDC 59762-1344 Pregabalin
Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
16 MM
PFIZER;PGN;50
Code Structure Chart
Product Details
What is NDC 59762-1344?
What are the uses for Pregabalin?
What are Pregabalin Active Ingredients?
- PREGABALIN 50 mg/1 - A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.
Which are Pregabalin UNII Codes?
The UNII codes for the active ingredients in this product are:
- PREGABALIN (UNII: 55JG375S6M)
- PREGABALIN (UNII: 55JG375S6M) (Active Moiety)
Which are Pregabalin 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:
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- STARCH, CORN (UNII: O8232NY3SJ)
- TALC (UNII: 7SEV7J4R1U)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- SHELLAC (UNII: 46N107B71O)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
What is the NDC to RxNorm Crosswalk for Pregabalin?
- RxCUI: 483438 - pregabalin 100 MG Oral Capsule
- RxCUI: 483440 - pregabalin 150 MG Oral Capsule
- RxCUI: 483442 - pregabalin 25 MG Oral Capsule
- RxCUI: 483444 - pregabalin 300 MG Oral Capsule
- RxCUI: 483446 - pregabalin 200 MG Oral Capsule
* Please review the disclaimer below.
Patient Education
Pregabalin
Pregabalin capsules, oral solution (liquid), and extended-release (long-acting) tablets are used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes and postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Pregabalin capsules and oral solution are also used to relieve neuropathic pain that can occur after a spinal cord injury and to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin capsules and oral solution are used along with other medications to treat certain types of seizures in adults and children 1 month of age and older. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
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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.
[7] What is the Drug Enforcement Administration (DEA) CV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[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.
[10] 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.
[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".