Prescription drug · ANDA
Quetiapine Extended Release (quetiapine) NDC 71093-138
Quetiapine fumarate 300 mg/1 · Tablet, Film coated, Extended release · Oral · ACI Healthcare USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71093-138-02 | 71093013802 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-138-02)Marketed from Feb 1, 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 — 300 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ACI Healthcare USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209635
- Marketing start
- Listing expires
- Identifiers
- Product ID 71093-138_8a3515c7-6fc7-4150-a898-23443e4802fdSPL ID 8a3515c7-6fc7-4150-a898-23443e4802fdSPL set ID 07e4f3f4-42cb-4b22-bf8d-8c3279d26e97RxCUI 721791, 721794, 721796, 853201, 895670UNII 2S3PL1B6UJUPC 0371093135024, 0371093137028, 0371093136021, 0371093138025
- 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
N471093013802followed by a unit qualifier and the quantityPackage 71093-0138-02. 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.
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 200 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, Inc | 50228-382 |
| 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 400 mg/1 | Tablet, Film coated, Extended releaseOral | ACI Healthcare USA, Inc. | 71093-139 |