Prescription drug · ANDA
Quetiapine Fumarate NDC 34908-638
Quetiapine fumarate 300 mg/1 · Tablet, Extended release · Oral · Novast Laboratories, Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34908-638-10 | 34908063810 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-10)Marketed from Aug 31, 2017 | |
| 34908-638-30 | 34908063830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-30)Marketed from Aug 31, 2017 | |
| 34908-638-60 | 34908063860 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-60)Marketed from Aug 31, 2017 | |
| 34908-638-90 | 34908063890 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-90)Marketed from Aug 31, 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 fumarate
- Active ingredients
- Quetiapine fumarate — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Novast Laboratories, Ltd.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208947
- Marketing start
- Listing expires
- Identifiers
- Product ID 34908-638_781f6242-bc94-424b-be23-ea9eb61c0889SPL ID 781f6242-bc94-424b-be23-ea9eb61c0889
- 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
N434908063810followed by a unit qualifier and the quantityPackage 34908-0638-10. 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 208947
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 150 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-636 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-635 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-639 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-637 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-638 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Novast Laboratories, Ltd. | 34908-636 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Novast Laboratories, Ltd. | 34908-637 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Novast Laboratories, Ltd. | 34908-639 |