Prescription drug · ANDA
Quetiapine fumarate NDC 71335-1362
Quetiapine fumarate 200 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1362-1 | 71335136201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1362-1)Marketed from Oct 3, 2019 | |
| 71335-1362-2 | 71335136202 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1362-2)Marketed from May 20, 2024 | |
| 71335-1362-3 | 71335136203 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1362-3)Marketed from May 20, 2024 | |
| 71335-1362-4 | 71335136204 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1362-4)Marketed from May 20, 2024 | |
| 71335-1362-5 | 71335136205 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1362-5)Marketed from May 20, 2024 |
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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203359
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1362_0a8804e2-28c3-4f92-bf7a-c26c8d00cc71SPL ID 0a8804e2-28c3-4f92-bf7a-c26c8d00cc71SPL set ID 293a9857-d138-4583-abc9-35b75660e324RxCUI 317174UNII 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
N471335136201followed by a unit qualifier and the quantityPackage 71335-1362-01. 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 treat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203359
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 100 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-101 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-099 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-100 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-105 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-103 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-104 |