27808-185 : Quetiapine Fumarate Extended-release 50 mg Oral Tablet, Extended Release

NDC:	27808-185
Labeler:	Tris Pharma Inc.
Product Type:	Human Prescription Drug
Drug Name:	Quetiapine Fumarate Extended-release
Dosage Form:	Oral Tablet, Extended Release
Application #:	ANDA202939
Rev. Date:	Nov 15, 2019

Appearance:

Markings:	Q50
Shapes:	Oval
Colors:	Red
Size (mm):	8
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:

27808-185-01: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (27808‑185‑01)

Active Ingredients:

Quetiapine Fumarate

Dosage Strength:

50 mg

Inactive Ingredients:

Anhydrous Lactose
Hypromellose, Unspecified
Ethylcellulose (100 Mpa.s)
Microcrystalline Cellulose
Hydroxyethyl Cellulose (4000 Mpa.s At 1%)
Magnesium Stearate
Polyethylene Glycol, Unspecified
Talc
Titanium Dioxide
Polyvinyl Alcohol, Unspecified
Ferric Oxide Yellow
Ferric Oxide Red /

Pharmaceutical Classes:

Atypical Antipsychotic [EPC]

NDC QR Code

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NDC 27808-185 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.