NDC 52427-815 Gralise
Gabapentin Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
BROWN (C48332 - BEIGE)
19 MM
SLV;600
Code Structure Chart
Product Details
What is NDC 52427-815?
What are the uses for Gralise?
Which are Gralise UNII Codes?
The UNII codes for the active ingredients in this product are:
- GABAPENTIN (UNII: 6CW7F3G59X)
- GABAPENTIN (UNII: 6CW7F3G59X) (Active Moiety)
Which are Gralise 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:
- COPOVIDONE K25-31 (UNII: D9C330MD8B)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TALC (UNII: 7SEV7J4R1U)
- POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
What is the NDC to RxNorm Crosswalk for Gralise?
- RxCUI: 1115012 - Gralise 300 MG Once-Daily Oral Tablet
- RxCUI: 1115012 - Once-Daily gabapentin 300 MG Oral Tablet [Gralise]
- RxCUI: 1115012 - Once-Daily Gralise 300 MG Oral Tablet
- RxCUI: 1115013 - Gralise 600 MG Once-Daily Oral Tablet
- RxCUI: 1115013 - Once-Daily gabapentin 600 MG Oral Tablet [Gralise]
* Please review the disclaimer below.
Patient Education
Gabapentin
Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.
[Learn More]
* 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.
[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.
[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.
[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".