16729-097 : Quetiapine Fumarate 400 mg Oral Tablet, Extended Release


NDC: 16729-097
Labeler: Accord Healthcare Inc.
Product Type: Human Prescription Drug
Drug Name:  Quetiapine Fumarate
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA090681
Rev. Date: 


Appearance:


Markings: I4
Shapes:  Round
Colors:  White
Size (mm): 13
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:

  • 16729-097-12: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (16729‑097‑12)

Active Ingredients:

  • Quetiapine Fumarate

Dosage Strength:

  • 400 mg

Inactive Ingredients:

  • Sodium Chloride
  • Povidone K30
  • Talc
  • Magnesium Stearate
  • Hypromellose 2910 (6 Mpa.s)
  • Polyethylene Glycol 400
  • Titanium Dioxide
  • Hypromellose 2208 (4000 Mpa.s)
  • Lactose Monohydrate

Pharmaceutical Classes:

  • Atypical Antipsychotic [EPC]

Related Products:

Based on records with the same trade name.
  • 16729-095 Quetiapine Fumarate 200 mg Oral Tablet, Extended Release by Accord Healthcare Inc.
  • 16729-096 Quetiapine Fumarate 300 mg Oral Tablet, Extended Release by Accord Healthcare Inc.
  • 16729-109 Quetiapine Fumarate 150 mg Oral Tablet, Extended Release by Accord Healthcare Inc.
  • 16729-132 Quetiapine Fumarate 50 mg Oral Tablet, Extended Release by Accord Healthcare Inc.
  • 16729-145 Quetiapine (As Quetiapine Fumarate) 25 mg Oral Tablet by Accord Healthcare Inc.
  • 16729-146 Quetiapine (As Quetiapine Fumarate) 50 mg Oral Tablet by Accord Healthcare Inc.
  • 16729-147 Quetiapine (As Quetiapine Fumarate) 100 mg Oral Tablet by Accord Healthcare Inc.
  • 16729-148 Quetiapine (As Quetiapine Fumarate) 200 mg Oral Tablet by Accord Healthcare Inc.
  • 16729-149 Quetiapine (As Quetiapine Fumarate) 300 mg Oral Tablet by Accord Healthcare Inc.
  • 16729-150 Quetiapine (As Quetiapine Fumarate) 400 mg Oral Tablet by Accord Healthcare Inc.
  • 0054-0220 Quetiapine (As Quetiapine Fumarate) 25 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0221 Quetiapine (As Quetiapine Fumarate) 100 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0222 Quetiapine (As Quetiapine Fumarate) 200 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0223 Quetiapine (As Quetiapine Fumarate) 300 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0229 Quetiapine (As Quetiapine Fumarate) 50 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0230 Quetiapine (As Quetiapine Fumarate) 400 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0093-2063 Quetiapine (As Quetiapine Fumarate) 25 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8161 Quetiapine (As Quetiapine Fumarate) 25 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8162 Quetiapine (As Quetiapine Fumarate) 100 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8163 Quetiapine (As Quetiapine Fumarate) 200 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • More related products ...

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.