Quetiapine Fumarate
- Product NDC
- 50090-3333
- 11-digit product format
- 500903333
- Labeler code
- 50090
- Product ID
- 50090-3333_79b326e6-2b92-429e-accc-361128c6dec3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744, 616487 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3333-0 | 50090333300 | 30 TABLET in 1 BOTTLE (50090-3333-0) | 30 tablet | 2018-01-16 | 0000-00-00 | No | No | Current |
| 50090-3333-1 | 50090333301 | 90 TABLET in 1 BOTTLE (50090-3333-1) | 90 tablet | 2024-12-11 | | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | A-S Medication Solutions | 2024-12-20 | Human Prescription Drug Label | 20 |