Prescription drug · ANDA
Quetiapine fumarate (quetiapine) NDC 67046-0636
Quetiapine fumarate 100 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0636-3 | 67046063603 | 30 TABLET in 1 BLISTER PACK (67046-0636-3)Marketed from Jun 1, 2026 |
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
- Active ingredients
- Quetiapine fumarate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-0636_5331516f-95e3-1075-e063-6294a90acd45SPL ID 5331516f-95e3-1075-e063-6294a90acd45SPL set ID 533154bb-a596-c88b-e063-6294a90a8956RxCUI 312743UNII 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
N467046063603followed by a unit qualifier and the quantityPackage 67046-0636-03. 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)
1. INDICATIONS AND USAGE Quetiapine 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 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 fo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201109
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 50 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8778 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2102 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-762 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-763 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2422 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2428 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-071 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6812 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3676 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-072 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3940 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0632 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Coupler LLC | 67046-0637 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Coupler LLC | 67046-0638 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2462 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 400 mg/1 | TabletOral | BluePoint Laboratories | 68001-181 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-180 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-185 |
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