NDC 0904-6804 – Quetiapine
Quetiapine Fumarate 300 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC0904-6804
Product details
- Brand name
- Quetiapine
- Generic name
- Quetiapine
- Labeler
- Major Pharmaceuticals
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA204203
- Marketed since
- August 22, 2017
- Listing expires
- December 31, 2027
- Pharmacologic class
- Atypical Antipsychotic
Active ingredients
- Quetiapine Fumarate 300 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0904-6804-61 | 100 BLISTER PACK in 1 CARTON (0904-6804-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | Aug 22, 2017 |
Recalls mentioning this NDC
- D-1002-2020 Mar 18, 2020 · Class III
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-1001-2020 Mar 18, 2020 · Class III
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-0999-2020 Mar 18, 2020 · Class III
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - D-1000-2020 Mar 18, 2020 · Class III
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Other Quetiapine products
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- 71093-138 Quetiapine Fumarate 300 mg/1 · Tablet, Film Coated, Extended Release · ACI Healthcare USA, Inc.
- 71093-137 Quetiapine Fumarate 200 mg/1 · Tablet, Film Coated, Extended Release · ACI Healthcare USA, Inc.
- 71093-139 Quetiapine Fumarate 400 mg/1 · Tablet, Film Coated, Extended Release · ACI Healthcare USA, Inc.
- 71093-135 Quetiapine Fumarate 50 mg/1 · Tablet, Film Coated, Extended Release · ACI Healthcare USA, Inc.
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- 51407-803 Quetiapine Fumarate 400 mg/1 · Tablet, Film Coated, Extended Release · Golden State Medical Supply, Inc.