Prescription drug · ANDA
Quetiapine fumarate NDC 47335-904
Quetiapine fumarate 100 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-904-18 | 47335090418 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-904-18)Marketed from Mar 28, 2012 | |
| 47335-904-61 | 47335090461 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-904-61) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 28, 2012 | |
| 47335-904-83 | 47335090483 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-904-83)Marketed from Mar 28, 2012 |
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 fumarate
- Active ingredients
- Quetiapine fumarate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201190
- Marketing start
- Listing expires
- Identifiers
- Product ID 47335-904_53310064-c86d-89f3-e063-6294a90a718bSPL ID 53310064-c86d-89f3-e063-6294a90a718bSPL set ID ffe52b98-9872-48c1-90fd-8fcd37c3432fRxCUI 312743, 312744, 312745, 317174, 616483, 616487UNII 2S3PL1B6UJUPC 0347335907889, 0347335906882, 0347335905885, 0347335903881, 0347335904888
- 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
N447335090418followed by a unit qualifier and the quantityPackage 47335-0904-18. 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 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 manic ep…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201190
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 | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1440 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2157 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2176 |
| Quetiapine fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-902 |
| Quetiapine fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-903 |
| Quetiapine fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-905 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-906 |
| Quetiapine fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-907 |
| Quetiapine fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0772 |