Prescription drug · ANDA
Quetiapine NDC 0904-6639
Quetiapine fumarate 50 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6639-61 | 00904663961 | 100 BLISTER PACK in 1 CARTON (0904-6639-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 1, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201504
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6639_493dac53-08c1-43d6-aeec-57b15b81609cSPL ID 493dac53-08c1-43d6-aeec-57b15b81609c
- 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
N400904663961followed by a unit qualifier and the quantityPackage 00904-6639-61. 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
The FDA listing for this product does not reference a label (SPL) set.
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 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 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | AvPAK | 50268-630 |
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