Prescription drug · ANDA
Quetiapine NDC 43547-518
Quetiapine fumarate 25 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-518-10 | 4354705181043547051810 | 100 TABLET in 1 BOTTLE (43547-518-10)Marketed from Apr 12, 2022 | |
| 43547-518-11 | 4354705181143547051811 | 1000 TABLET in 1 BOTTLE (43547-518-11)Marketed from Apr 12, 2022 |
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
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206954
- Marketing start
- Listing expires
- Identifiers
- Product ID 43547-518_c91f8a6b-86e3-40a5-befe-4617aa36c718SPL ID c91f8a6b-86e3-40a5-befe-4617aa36c718SPL set ID 61b1230e-c0dc-46c6-a577-7d5dd2515eb7RxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0343547519100, 0343547520106, 0343547518103, 0343547523107, 0343547522063, 0343547521103
- 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
N443547051810followed by a unit qualifier and the quantityPackage 43547-0518-10. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Quetiapine tablets are atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes ( 1.2 ) • Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies ( 14.1 ) ] . 1.2 Bipolar Disorder Quetiapine tablets are indicated for the acute treatmen…
Excerpt only. Read the full label for complete information.
About NDC 43547-518
- What is NDC 43547-518?
- 43547-518 is the product NDC for Quetiapine, Quetiapine fumarate 25 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, 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?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4437 | 70518-4437-00 |
| 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 |
Other NDCs under ANDA 206954
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 50 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-519 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-520 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-521 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-522 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-523 |