Prescription drug · ANDA
Quetiapine Extended Release (quetiapine) NDC 50228-382
Quetiapine fumarate 200 mg/1 · Tablet, Film coated, Extended release · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-382-10 | 50228038210 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-10)Marketed from Nov 29, 2017 | |
| 50228-382-30 | 50228038230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-30)Marketed from Nov 29, 2017 | |
| 50228-382-60 | 50228038260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-382-60)Marketed from Nov 29, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Quetiapine Extended ReleaseSuffix: Extended Release
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 200 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
- Listing expires
- Identifiers
- Product ID 50228-382_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
N450228038210followed by a unit qualifier and the quantityPackage 50228-0382-10. 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3921 |
| Quetiapine Fumarate ER | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 72189-519 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-866 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-383 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-800 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-380 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-381 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-799 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-803 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-384 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-801 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-802 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4051 |
| Quetiapine Fumarate ER | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-586 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-136 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-135 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-137 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-138 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-139 |