Prescription drug · ANDA
Quetiapine fumarate NDC 71335-2462
Quetiapine fumarate 400 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2462-1 | 7133524620171335246201 | 30 TABLET in 1 BOTTLE (71335-2462-1)Marketed from Oct 1, 2024 | |
| 71335-2462-2 | 7133524620271335246202 | 28 TABLET in 1 BOTTLE (71335-2462-2)Marketed from Feb 3, 2025 | |
| 71335-2462-3 | 7133524620371335246203 | 60 TABLET in 1 BOTTLE (71335-2462-3)Marketed from Dec 13, 2024 | |
| 71335-2462-4 | 7133524620471335246204 | 180 TABLET in 1 BOTTLE (71335-2462-4)Marketed from Feb 3, 2025 | |
| 71335-2462-5 | 7133524620571335246205 | 90 TABLET in 1 BOTTLE (71335-2462-5)Marketed from Aug 1, 2024 |
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 fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201109
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2462_d98d1381-2bb8-4dd6-a247-635ec2d2651bSPL ID d98d1381-2bb8-4dd6-a247-635ec2d2651bSPL set ID 35f6ad40-192a-4d1f-ace0-9fb69b9d984dRxCUI 616483UNII 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
N471335246201followed by a unit qualifier and the quantityPackage 71335-2462-01. 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 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 for the acute treatment of …
Excerpt only. Read the full label for complete information.
About NDC 71335-2462
- What is NDC 71335-2462?
- 71335-2462 is the product NDC for Quetiapine fumarate, Quetiapine fumarate 400 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine fumarate.
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 211 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 fumaratequetiapine | Quetiapine fumarate 200 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-073 | 87441-0073-01 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 | 87441-0074-01 |
| 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 25 mg/1 | TabletOral | Coupler LLC | 67046-1116 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2752 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8745 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8746 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2901 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | : Preferred Pharmaceuticals Inc. | 68788-8764 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0413 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8778 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1918 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2278 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1919 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-448 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-445 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-446 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-447 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-449 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-450 |
| Quetiapine fumarate | Quetiapine fumarate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6812 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-074 |
| Quetiapine fumaratequetiapine | Quetiapine fumarate 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-071 |
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