Prescription drug · ANDA
Quetiapine Fumarate ER NDC 72189-483
Quetiapine fumarate 400 mg/1 · Tablet, Extended release · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-483-30 | 72189048330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-483-30)Marketed from Jun 1, 2023 |
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 ER
- Generic name (nonproprietary)
- quetiapine fumarate er
- Active ingredients
- Quetiapine fumarate — 400 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090681
- Marketing start
- Listing expires
- Identifiers
- Product ID 72189-483_2c4e19ad-8322-dd6e-e063-6394a90aead0SPL ID 2c4e19ad-8322-dd6e-e063-6394a90aead0SPL set ID fd17163f-a308-5c9a-e053-6294a90a2ae6RxCUI 721796UNII 2S3PL1B6UJ
- 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
N472189048330followed by a unit qualifier and the quantityPackage 72189-0483-30. 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)
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) treated with quetiapine tablets [see Clinical Studies (14.1)]. 1.2 Bipolar Disorder Quetiapine Extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The effic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090681
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 ER | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-481 |
| Quetiapine Fumarate ER | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-482 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-097 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-095 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-096 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-109 |