Quetiapine Extended Release (quetiapine) NDC 50228-383

Product information

Brand name (proprietary)

Quetiapine Extended ReleaseSuffix: Extended Release

Generic name (nonproprietary)

quetiapine

Active ingredients

Quetiapine fumarate — 300 mg/1

Dosage form

Tablet, Film coated, Extended release

Route

Oral

Labeler

ScieGen Pharmaceuticals, Inc

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 209635

Marketing start

Nov 29, 2017

Listing expires

Dec 31, 2027

Identifiers

Product ID 50228-383_47ce17ad-f0c0-8ce7-e063-6294a90a7520SPL ID 47ce17ad-f0c0-8ce7-e063-6294a90a7520SPL set ID 5e4a84b1-fb8c-44d0-8213-51e43d71db69RxCUI 721791, 721794, 721796, 853201, 895670UNII 2S3PL1B6UJUPC 0350228380607, 0350228382601, 0350228384605, 0350228381604, 0350228383608

Pharmacologic class

Atypical Antipsychotic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450228038305 followed by a unit qualifier and the quantity Copy

Package 50228-0383-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 209635

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.