Prescription drug · ANDA
Quetiapine NDC 71205-026
Quetiapine fumarate 300 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-026-03 | 71205002603 | 3 TABLET, FILM COATED in 1 BOTTLE (71205-026-03)Marketed from May 1, 2018 | |
| 71205-026-30 | 71205002630 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-026-30)Marketed from May 1, 2018 | |
| 71205-026-60 | 71205002660 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-026-60)Marketed from May 1, 2018 | |
| 71205-026-90 | 71205002690 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-026-90)Marketed from May 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
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077745
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-026_7a3de2bf-32a1-465e-ae85-bd7e1ad1b205SPL ID 7a3de2bf-32a1-465e-ae85-bd7e1ad1b205SPL set ID dd6b6088-943e-413b-9886-88dd9c622be4RxCUI 312745UNII 2S3PL1B6UJUPC 0371205026301
- 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
N471205002603followed by a unit qualifier and the quantityPackage 71205-0026-03. 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)
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 bip…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077745
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 400 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8165 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8162 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8163 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8164 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8166 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-402 |
| Quetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-2063 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-702 |