Prescription drug · ANDA
Quetiapine Fumarate (Quetiapine) NDC 65862-873
Quetiapine fumarate 50 mg/1 · Tablet, Film coated, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-873-01 | 65862087301 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-873-01)Marketed from Nov 29, 2017 | |
| 65862-873-05 | 65862087305 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-873-05)Marketed from Nov 29, 2017 | |
| 65862-873-60 | 65862087360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-873-60)Marketed from Nov 29, 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
- Active ingredients
- Quetiapine fumarate — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207655
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-873_631d518f-bb71-4848-98a6-f9335dc5b33bSPL ID 631d518f-bb71-4848-98a6-f9335dc5b33bSPL set ID 6562eb60-0d70-4909-bd07-88d5c9241516RxCUI 721791, 721794, 721796, 853201, 895670UNII 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
N465862087301followed by a unit qualifier and the quantityPackage 65862-0873-01. 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 extended-release tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic, or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated …
Excerpt only. Read the full label for complete information.
About NDC 65862-873
- What is NDC 65862-873?
- 65862-873 is the product NDC for Quetiapine Fumarate (quetiapine), Quetiapine fumarate 50 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine Fumarate (Quetiapine).
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quetiapine Fumarate?
- 214 other product NDCs are listed under this name. See all Quetiapine Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4701 | 70518-4701-00 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4705 | 70518-4705-00 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 25 mg/1 | TabletOral | Coupler LLC | 67046-1116 | 67046-1116-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 | 87441-0073-01 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 | 87441-0074-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-071 | 87441-0071-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-072 | 87441-0072-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Coupler LLC | 67046-0638 | 67046-0638-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0636 | 67046-0636-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Coupler LLC | 67046-0637 | 67046-0637-03 |
Other NDCs under ANDA 207655
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 Fumaratequetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-877 |
| Quetiapine Fumaratequetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-875 |
| Quetiapine Fumaratequetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-876 |
| Quetiapine Fumaratequetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-874 |