NDC 0904-6803

Quetiapine 200 mg tablet, film coated, extended release

On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-614.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Lupin Limited	Pithampur, India	Makes it and packages it	Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action

Feb 27, 2020 · Class III · The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Lots: Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021
Feb 27, 2020 · Class III · The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Lots: Lot, expiry: Lot N00036, exp 05/2021
Feb 27, 2020 · Class III · The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Lots: Lot, expiry: Lot N00037, exp 05/2021
Feb 27, 2020 · Class III · The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Lots: Lot, expiry: Lot N00037, exp 05/2021

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

Generic drug: Quetiapine: every company that makes it
Form: tablet, film coated, extended release, oral
Strength: 200 mg
Approval: ANDA ANDA204203
On the market since: Aug 22, 2017
Package NDCs: 0904-6803-61
Official label: DailyMed (National Library of Medicine), updated Jul 16, 2026

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?