Prescription drug · ANDA
Quetiapine Extended Release (Quetiapine) NDC 50228-380
Quetiapine fumarate 50 mg/1 · Tablet, Film coated, Extended release · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-380-10 | 5022803801050228038010 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-380-10)Marketed from Nov 16, 2018 | |
| 50228-380-30 | 5022803803050228038030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-380-30)Marketed from Nov 16, 2018 | |
| 50228-380-60 | 5022803806050228038060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-380-60)Marketed from Nov 16, 2018 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, IncNDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209635
- Marketing start
- Listing expires
- Identifiers
- Product ID 50228-380_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
N450228038010followed by a unit qualifier and the quantityPackage 50228-0380-10. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated w…
Excerpt only. Read the full label for complete information.
About NDC 50228-380
- What is NDC 50228-380?
- 50228-380 is the product NDC for Quetiapine Extended Release (quetiapine), Quetiapine fumarate 50 mg/1 tablet, film coated, extended release, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine Extended Release (Quetiapine).
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc, NDC labeler code 50228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quetiapine Extended Release?
- 20 other product NDCs are listed under this name. See all Quetiapine Extended Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine Extended Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4769 | 70518-4769-00 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4051 | 70518-4051-00 |
| Quetiapine Extended-Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | AlignScience Pharma Inc. | 69948-002 | 69948-0002-0369948-0002-11 |
| Quetiapine Extended-Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | AlignScience Pharma Inc. | 69948-003 | 69948-0003-0369948-0003-11 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-799 | 51407-0799-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-381 | 50228-0381-1050228-0381-3050228-0381-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-382 | 50228-0382-1050228-0382-3050228-0382-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-383 | 50228-0383-0550228-0383-3050228-0383-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-384 | 50228-0384-0550228-0384-3050228-0384-60 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-800 | 51407-0800-60 |
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 200 mg/1 | Tablet, Film coated, Extended releaseOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-866 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-381 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-382 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-383 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-384 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4051 |
| 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 50 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-799 |
| 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 200 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-801 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-803 |
| Quetiapine Fumarate ER | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_Rx | 72189-519 |
| 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 Fumarate ER | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-586 |
| 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 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3921 |
| Quetiapine Extended Releasequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4769 |