| PRODUCT NDC | 63187-231 | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | 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. |
| PROPRIETARY NAME | Gabapentin | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| NON PROPRIETARY NAME | Gabapentin | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | TABLET | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | 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. |
| START MARKETING DATE | 10/29/2012 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| MARKETING CATEGORY NAME | ANDA | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| APPLICATION NUMBER | ANDA202764 | The translation of the dosage form Code submitted by the firm. |
| LABELER NAME | Proficient Rx LP | The translation of the route code submitted by the firm, indicating route of administration. |
| SUBSTANCE NAME | GABAPENTIN | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| ACTIVE NUMERATOR STRENGTH | 800 | |
| ACTIVE INGRED UNIT | mg/1 | |
| PHARM CLASSES | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] | |