Prescription drug · ANDA
Quetiapine Fumarate NDC 51407-070
Quetiapine fumarate 300 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-070-05 | 51407007005 | 500 TABLET in 1 BOTTLE (51407-070-05)Marketed from Oct 30, 2018 | |
| 51407-070-60 | 51407007060 | 60 TABLET in 1 BOTTLE (51407-070-60)Marketed from Mar 26, 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 Fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090749
- Marketing start
- Listing expires
- Identifiers
- Product ID 51407-070_31e6a4fb-7f18-d5a4-e063-6394a90acfb3SPL ID 31e6a4fb-7f18-d5a4-e063-6394a90acfb3SPL set ID 6fc9c8e2-6f34-aa43-e053-2a91aa0ac377RxCUI 312743, 312744, 312745, 317174, 616483, 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
N451407007005followed by a unit qualifier and the quantityPackage 51407-0070-05. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090749
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 Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-067 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0222 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-071 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-068 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-069 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-127 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-128 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-136 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-141 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0230 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0223 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0221 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0229 |