NDC 63874-489

Naproxen Sodium 275 mg tablet

On the label: Altura Pharmaceuticals, Inc.. It's repackaged: Altura Pharmaceuticals, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-178.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Glenmark Pharmaceuticals Inc., USA	Monroe, NC, United States	Makes it and tests it	Problems found, fixed voluntarilyJun 17, 2025 · 2 inspections, 1 with FDA action
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 # 17231956, exp. date Aug-25
Nov 7, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Lots: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025
Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022
Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022
Jul 6, 2012 · Class II · Glenmark Generics Inc., USA
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Lots: Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.

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

Generic drug: Naproxen: every company that makes it
Form: tablet
Strength: 275 mg
Approval: ANDA ANDA078314
On the market since: Jan 1, 2010
Package NDCs: 63874-489-01 63874-489-30 63874-489-60 63874-489-90
Official label: DailyMed (National Library of Medicine), updated Apr 27, 2010

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