Prescription drug · ANDA
Quetiapine Fumarate NDC 34908-639
Quetiapine fumarate 400 mg/1 · Tablet, Extended release · Oral · Novast Laboratories, Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34908-639-10 | 34908063910 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-10)Marketed from Aug 31, 2017 | |
| 34908-639-30 | 34908063930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-30)Marketed from Aug 31, 2017 | |
| 34908-639-60 | 34908063960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-60)Marketed from Aug 31, 2017 | |
| 34908-639-90 | 34908063990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-90)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 — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Novast Laboratories, Ltd.NDC labeler code 34908
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208947
- Marketing start
- Listing expires
- Identifiers
- Product ID 34908-639_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
N434908063910followed by a unit qualifier and the quantityPackage 34908-0639-10. 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.
About NDC 34908-639
- What is NDC 34908-639?
- 34908-639 is the product NDC for Quetiapine Fumarate, Quetiapine fumarate 400 mg/1 tablet, extended release, listed with the FDA by Novast Laboratories, Ltd.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine Fumarate.
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- Novast Laboratories, Ltd., NDC labeler code 34908. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quetiapine Fumarate?
- 208 other product NDCs are listed under this name. See all Quetiapine Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4701 | 70518-4701-00 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4705 | 70518-4705-00 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 25 mg/1 | TabletOral | Coupler LLC | 67046-1116 | 67046-1116-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 | 87441-0073-01 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 | 87441-0074-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-071 | 87441-0071-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-072 | 87441-0072-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Coupler LLC | 67046-0638 | 67046-0638-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0636 | 67046-0636-03 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Coupler LLC | 67046-0637 | 67046-0637-03 |
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 | Novast Laboratories, Ltd. | 34908-636 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Novast Laboratories, Ltd. | 34908-637 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Novast Laboratories, Ltd. | 34908-638 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-635 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-636 |
| 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 400 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-639 |