Prescription drug · ANDA
Quetiapine NDC 43547-022
Quetiapine 300 mg/1 · Tablet, Extended release · Oral · Solco Healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-022-06 | 43547002206 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-06)Marketed from Apr 1, 2022 | |
| 43547-022-50 | 43547002250 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-022-50)Marketed from Apr 1, 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 — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Solco Healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208781
- Marketing start
- Listing expires
- Identifiers
- Product ID 43547-022_058aac79-3e9f-46b2-a2f8-693ffb211aefSPL ID 058aac79-3e9f-46b2-a2f8-693ffb211aefSPL set ID b0cce89c-0e84-4f60-8e50-0e26c41c2613RxCUI 721791, 721794, 721796, 853201, 895670UNII BGL0JSY5SI
- 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
N443547002206followed by a unit qualifier and the quantityPackage 43547-0022-06. 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 extended-release tablets are an atypical antipsychotic indicated for the treatment of: • Schizophrenia (1.1) • Bipolar I disorder, manic, or mixed episodes (1.2) • Bipolar disorder, depressive episodes (1.2) • Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) …
Excerpt only. Read the full label for complete information.
About NDC 43547-022
- What is NDC 43547-022?
- 43547-022 is the product NDC for Quetiapine, Quetiapine 300 mg/1 tablet, extended release, listed with the FDA by Solco Healthcare U.S., 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.
- Who is the labeler?
- Solco Healthcare U.S., 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 208781
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 50 mg/1 | Tablet, Extended releaseOral | Solco Healthcare U.S., LLC | 43547-019 |
| Quetiapine | Quetiapine 150 mg/1 | Tablet, Extended releaseOral | Solco Healthcare U.S., LLC | 43547-020 |
| Quetiapine | Quetiapine 200 mg/1 | Tablet, Extended releaseOral | Solco Healthcare U.S., LLC | 43547-021 |
| Quetiapine | Quetiapine 400 mg/1 | Tablet, Extended releaseOral | Solco Healthcare U.S., LLC | 43547-023 |