Prescription drug · ANDA
Quetiapine Fumarate NDC 80425-0186
Quetiapine fumarate 50 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0186-3 | 80425018603 | 90 TABLET in 1 BOTTLE (80425-0186-3)Marketed from Mar 1, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0186_2a99a7f4-89eb-19db-e063-6294a90a90daSPL ID 2a99a7f4-89eb-19db-e063-6294a90a90daSPL set ID d2a76aed-a0b8-33f0-e053-2a95a90add0fRxCUI 616487UNII 2S3PL1B6UJ
- 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
N480425018603followed by a unit qualifier and the quantityPackage 80425-0186-03. 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)
1. Indications and Usage 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1)]. 1.2 Bipolar Disorder Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201504
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 | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6639 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4451 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3359 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5884 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0926 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3599 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8092 |
| Quetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6638 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Proficient Rx LP | 71205-031 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1462 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-446 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6640 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8823 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0487 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6641 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-3333 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-5473 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-3342 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | AvPAK | 50268-632 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | AvPAK | 50268-630 |
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