NDC 0440-5563 Gabapentin

Product Information

Product Code0440-5563
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Gabapentin
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Liberty Pharmaceuticals, Inc.
Labeler Code0440
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-02-2012
Listing Expiration Date 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.
12-31-2018
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeCAPSULE (C48336)
Size(s)17 MM
19 MM
Imprint(s)1;2
1;3
Score2

Product Packages

NDC 0440-5563-05

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-60

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-81

Package Description: 300 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-90

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-91

Package Description: 120 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-92

Package Description: 180 TABLET, FILM COATED in 1 BOTTLE

NDC 0440-5563-94

Package Description: 270 TABLET, FILM COATED in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Gabapentin is product labeled by Liberty Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.


What are Gabapentin Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • GABAPENTIN (UNII: 6CW7F3G59X)
  • GABAPENTIN (UNII: 6CW7F3G59X) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? 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:


Inactive Ingredient(s)

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.

  • MANNITOL (UNII: 3OWL53L36A)
  • HYDROXYPROPYL CELLULOSE (120000 MW) (UNII: UKE75GEA7F)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • TALC (UNII: 7SEV7J4R1U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • MANNITOL (UNII: 3OWL53L36A)
  • HYDROXYPROPYL CELLULOSE (120000 MW) (UNII: UKE75GEA7F)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • TALC (UNII: 7SEV7J4R1U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)


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Patient Education

Gabapentin

Gabapentin is pronounced as (ga' ba pen tin)

Why is gabapentin medication prescribed?
Gabapentin capsules, tablets, and oral solution are used to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral sol...
[Read More]

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Gabapentin Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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