Prescription drug · ANDA
Quetiapine fumarate NDC 63187-452
Quetiapine fumarate 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-452-03 | 63187045203 | 3 TABLET, FILM COATED in 1 BOTTLE (63187-452-03)Marketed from May 1, 2017 | |
| 63187-452-30 | 63187045230 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-452-30)Marketed from May 1, 2017 |
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 — 25 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 202152
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-452_72502e4b-1ebb-4a61-aecf-f319be11ce9bSPL ID 72502e4b-1ebb-4a61-aecf-f319be11ce9bSPL set ID 1a147d6c-8af8-4379-8a13-1864a9a79b84RxCUI 312744UNII 2S3PL1B6UJUPC 0363187452308
- 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
N463187045203followed by a unit qualifier and the quantityPackage 63187-0452-03. 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 fumarate tablet 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 fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate 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 fumarate 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 fumarate ta…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202152
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 | Accord Healthcare Inc. | 16729-150 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-147 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-148 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-149 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-219 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-269 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4776 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4841 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-401 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4964 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7116 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-146 |
| Quetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-145 |