0310-8284 : Quetiapine Fumarate Extended Release 400 mg Oral Tablet, Film Coated, Extended Release


NDC: 0310-8284
Labeler: Astrazeneca Pharmaceuticals Lp
Product Type: Human Prescription Drug
Drug Name:  Quetiapine Fumarate Extended Release
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA022047
Rev. Date: 


Appearance:


Markings: XR;400
Shapes:  Capsule
Colors:  White
Size (mm): 17
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0310-8284-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0310‑8284‑60)

Active Ingredients:

  • Quetiapine Fumarate

Dosage Strength:

  • 400 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Cellulose, Microcrystalline
  • Sodium Citrate, Unspecified Form
  • Hypromelloses
  • Magnesium Stearate
  • Polyethylene Glycol 400
  • Titanium Dioxide
  • Water

Pharmaceutical Classes:

  • Atypical Antipsychotic [EPC]

Related Products:

Based on records with the same trade name.
  • 0310-8280 Quetiapine Fumarate Extended Release 50 mg Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
  • 0310-8281 Quetiapine Fumarate Extended Release 150 mg Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
  • 0310-8282 Quetiapine Fumarate Extended Release 200 mg Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
  • 0310-8283 Quetiapine Fumarate Extended Release 300 mg Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
  • 0406-1180 Quetiapine Fumarate Extended-release 50 mg Oral Tablet, Extended Release by Mallinckrodt Inc
  • 0406-1181 Quetiapine Fumarate Extended-release 150 mg Oral Tablet, Extended Release by Mallinckrodt Inc
  • 0406-1182 Quetiapine Fumarate Extended-release 200 mg Oral Tablet, Extended Release by Mallinckrodt Inc
  • 0406-1183 Quetiapine Fumarate Extended-release 300 mg Oral Tablet, Extended Release by Mallinckrodt Inc
  • 0406-1184 Quetiapine Fumarate Extended-release 400 mg Oral Tablet, Extended Release by Mallinckrodt Inc
  • 27808-185 Quetiapine Fumarate Extended-release 50 mg Oral Tablet, Extended Release by Tris Pharma Inc.
  • 27808-186 Quetiapine Fumarate Extended-release 150 mg Oral Tablet, Extended Release by Tris Pharma Inc.
  • 27808-187 Quetiapine Fumarate Extended-release 200 mg Oral Tablet, Extended Release by Tris Pharma Inc.
  • 27808-188 Quetiapine Fumarate Extended-release 300 mg Oral Tablet, Extended Release by Tris Pharma Inc.
  • 27808-189 Quetiapine Fumarate Extended-release 400 mg Oral Tablet, Extended Release by Tris Pharma Inc.
  • 49884-805 Quetiapine Fumarate Extended Release 50 mg Oral Tablet, Extended Release by Par Pharmaceutical Inc.
  • 49884-806 Quetiapine Fumarate Extended Release 150 mg Oral Tablet, Extended Release by Par Pharmaceutical Inc.
  • 49884-807 Quetiapine Fumarate Extended Release 200 mg Oral Tablet, Extended Release by Par Pharmaceutical Inc.
  • 49884-808 Quetiapine Fumarate Extended Release 300 mg Oral Tablet, Extended Release by Par Pharmaceutical Inc.
  • 70518-0646 Quetiapine Fumarate Extended Release 200 mg Oral Tablet, Film Coated, Extended Release by Remedyrepack Inc.

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.