Prescription drug · ANDA
Quetiapine Fumarate NDC 72189-366
Quetiapine fumarate 50 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-366-30 | 72189036630 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-366-30)Marketed from Jul 27, 2022 | |
| 72189-366-60 | 72189036660 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-366-60)Marketed from Jul 27, 2022 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-366_37b38291-50c8-00c9-e063-6394a90a83efSPL ID 37b38291-50c8-00c9-e063-6394a90a83efSPL set ID e4ce9d50-9786-2233-e053-2a95a90a276fRxCUI 616487UNII 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
N472189036630followed by a unit qualifier and the quantityPackage 72189-0366-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 201504
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 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6639 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4451 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3359 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5884 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0926 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3599 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0186 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8092 |
| Quetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6638 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Proficient Rx LP | 71205-031 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1462 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-446 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6640 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8823 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0487 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6641 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-3333 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-5473 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-3342 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | AvPAK | 50268-632 |
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