Prescription drug · ANDA
Quetiapine Fumarate NDC 71335-1353
Quetiapine fumarate 50 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1353-1 | 71335135301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1353-1)Marketed from Nov 5, 2019 | |
| 71335-1353-2 | 71335135302 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1353-2)Marketed from Oct 3, 2019 | |
| 71335-1353-3 | 71335135303 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1353-3)Marketed from Sep 26, 2019 | |
| 71335-1353-4 | 71335135304 | 25 TABLET, FILM COATED in 1 BOTTLE (71335-1353-4)Marketed from May 20, 2024 | |
| 71335-1353-5 | 71335135305 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1353-5)Marketed from May 20, 2024 |
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 fumarate
- Active ingredients
- Quetiapine fumarate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202674
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1353_a2688211-bc1c-463d-90e5-47476a140965SPL ID a2688211-bc1c-463d-90e5-47476a140965SPL set ID 1618989e-2e6b-49ff-81b5-cf80d1dcfab4RxCUI 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
N471335135301followed by a unit qualifier and the quantityPackage 71335-1353-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 202674
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 200 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8473 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2175 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3747 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8470 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0184 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8471 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8472 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-150 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-148 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-149 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-151 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8474 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-152 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8568 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3377 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3931 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-147 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3983 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1649 |