Prescription drug · ANDA
Quetiapine Fumarate NDC 16714-378
Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-378-01 | 16714037801 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-378-01)Marketed from Mar 27, 2012 |
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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091388
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-378_77b48f8a-7cb7-448d-bc92-1ed35b2f424aSPL ID 77b48f8a-7cb7-448d-bc92-1ed35b2f424aSPL set ID e6e25ef9-2671-489e-8eca-58bedb4f59abRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0316714377018, 0316714375014, 0316714376011
- 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
N416714037801followed by a unit qualifier and the quantityPackage 16714-0378-01. 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 tablets are 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 tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets 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 tablets 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 tablets are indicated for the acute treatment of mani…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091388
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 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3609 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1669 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8530 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2679 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-465 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2691 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8859 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-477 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6337 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2333 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3933 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9627 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9623 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-489 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3429 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-020 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-493 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-490 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-491 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-492 |
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