NDC 67046-229

Gabapentin 800 mg tablet

On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-127.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Appco Pharma LLC	Piscataway, NJ, United States	Makes it and tests it	Problems found, fixed voluntarilyMay 14, 2026 · 9 inspections
Glenmark Pharmaceuticals Limited	Goa, India	Makes it and tests it	Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action
Glenmark Pharmaceuticals Limited	Dhar, India	Makes it and tests it	Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action

Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug…
Apr 5, 2013 · Class III · Glenmark Generics Inc., USA
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Lots: a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14…

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Gabapentin: every company that makes it
Form: tablet
Strength: 800 mg
Approval: ANDA ANDA077662
On the market since: Oct 2, 2017
Package NDCs: 67046-229-07 67046-229-14 67046-229-15 67046-229-20 67046-229-21 67046-229-28 67046-229-30 67046-229-60
Official label: DailyMed (National Library of Medicine), updated Oct 2, 2017

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