Prescription drug · ANDA
Quetiapine NDC 70518-4437
Quetiapine fumarate 400 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4437-0 | 7051844370070518443700 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4437-0)Marketed from Aug 13, 2025 |
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
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215478
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4437_5b34d8e7-ab9d-2ed8-e063-6294a90a9945SPL ID 5b34d8e7-ab9d-2ed8-e063-6294a90a9945
- 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
N470518443700followed by a unit qualifier and the quantityPackage 70518-4437-00. 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 70518-4437
- What is NDC 70518-4437?
- 70518-4437 is the product NDC for Quetiapine, Quetiapine fumarate 400 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine.
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 86 other product NDCs are listed under this name. See all Quetiapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine 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 | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4700 | 70518-4700-00 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4699 | 70518-4699-00 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0487 | 67046-0487-03 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1623 | 67046-1623-03 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4451 | 70518-4451-00 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4430 | 70518-4430-0070518-4430-01 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-598 | 68001-0598-06 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-599 | 68001-0599-06 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-600 | 68001-0600-06 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-601 | 68001-0601-06 |
Other NDCs under ANDA 215478
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 200 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1623 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4430 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-310 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-308 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-309 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-311 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-312 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2641 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-598 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-599 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-600 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-601 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-602 |