Quetiapine Fumarate
- Product NDC
- 72189-465
- 11-digit product format
- 721890465
- Labeler code
- 72189
- Product ID
- 72189-465_2c4ded5c-1186-6387-e063-6294a90a6ab9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2023-05-03
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-465-30 | 72189046530 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-465-30) | 2023-05-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Direct_Rx | 2025-01-22 | HUMAN PRESCRIPTION DRUG LABEL | 2 |