NDC 10135-645 Gabapentin

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10135-645
Proprietary Name:
Gabapentin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Start Marketing Date: [9]
04-01-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OPAQUE WHITE COLORED CAP AND OPAQUE WHITE COLORED BODY)
YELLOW (C48330 - OPAQUE YELLOW COLORED CAP AND OPAQUE YELLOW COLORED BODY)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
19 MM
Imprint(s):
SG;179
SG;180
Score:
1

Product Packages

NDC Code 10135-645-01

Package Description: 100 CAPSULE in 1 BOTTLE, PLASTIC

NDC Code 10135-645-05

Package Description: 500 CAPSULE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 10135-645?

The NDC code 10135-645 is assigned by the FDA to the product Gabapentin which is product labeled by Marlex Pharmaceuticals Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 10135-645-01 100 capsule in 1 bottle, plastic , 10135-645-05 500 capsule in 1 bottle, plastic . 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 Gabapentin?

Gabapentin is used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection) in adults. Gabapentin is known as an anticonvulsant or antiepileptic drug.

Which are Gabapentin UNII Codes?

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

Which are Gabapentin 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 Gabapentin?

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:

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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.
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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".