Prescription drug · ANDA
Quetiapine fumarate (Quetiapine) NDC 68001-184
Quetiapine fumarate 100 mg/1 · Tablet · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-184-00 | 68001018400 | 100 TABLET in 1 BOTTLE (68001-184-00)Marketed from Feb 28, 2013 | |
| 68001-184-08 | 68001018408 | 1000 TABLET in 1 BOTTLE (68001-184-08)Marketed from Feb 28, 2013 |
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
- Active ingredients
- Quetiapine fumarate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
- Marketing start
- Listing expires
- Identifiers
- Product ID 68001-184_4e775bd2-4ec9-32b4-e063-6294a90acf3dSPL ID 4e775bd2-4ec9-32b4-e063-6294a90acf3dSPL set ID 874e50ad-5da0-4ac3-9290-79442c91399eRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0368001184007, 0368001185004, 0368001180009, 0368001182003, 0368001181006, 0368001183062
- 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
N468001018400followed by a unit qualifier and the quantityPackage 68001-0184-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Quetiapine tablet is an 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 to 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 fo…
Excerpt only. Read the full label for complete information.
About NDC 68001-184
- What is NDC 68001-184?
- 68001-184 is the product NDC for Quetiapine fumarate (quetiapine), Quetiapine fumarate 100 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine fumarate (Quetiapine).
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. 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?
- 214 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 fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 | 87441-0074-01 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 | 87441-0073-01 |
| 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 201109
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 fumaratequetiapine | Quetiapine fumarate 400 mg/1 | TabletOral | BluePoint Laboratories | 68001-181 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-182 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | BluePoint Laboratories | 68001-183 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2428 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3676 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6812 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3940 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0632 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | Coupler LLC | 67046-0636 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Coupler LLC | 67046-0637 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | Coupler LLC | 67046-0638 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2462 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-180 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0413 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 25 mg/1 | TabletOral | American Health Packaging | 60687-327 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | American Health Packaging | 60687-338 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | American Health Packaging | 60687-360 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 100 mg/1 | TabletOral | American Health Packaging | 60687-349 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 300 mg/1 | TabletOral | American Health Packaging | 60687-371 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 400 mg/1 | TabletOral | American Health Packaging | 60687-382 |
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