63304-628 NDC - GABAPENTIN ()

Drug Information

Product NDC: 63304-628
Proprietary Name: Gabapentin
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	Ranbaxy Pharmaceuticals Inc.
Product Type:
FDA Application Number:	ANDA076606
Marketing Category:	ANDA
Start Marketing Date:	11/2/2005

Package Information

No.	Package Code	Package Description	Billing Unit
1	63304-628-01	100 CAPSULE in 1 BOTTLE (63304-628-01)	EA
2	63304-628-05	500 CAPSULE in 1 BOTTLE (63304-628-05)	EA
3	63304-628-30	30 CAPSULE in 1 BOTTLE (63304-628-30)
4	63304-628-51	50 BLISTER PACK in 1 CARTON (63304-628-51) / 1 CAPSULE in 1 BLISTER PACK

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63304-628	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
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.
START MARKETING DATE	11/2/2005	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	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.
APPLICATION NUMBER	ANDA076606	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.
LABELER NAME	Ranbaxy Pharmaceuticals Inc.	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.

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This page was last updated on: 12/19/2025

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