QUETIAPINE
- Product NDC
- 63629-5944
- 11-digit product format
- 636295944
- Labeler code
- 63629
- Product ID
- 63629-5944_4a02e4f5-8be5-46ca-93f2-9c33f873beb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- QUETIAPINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204253
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 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 |
| BGL0JSY5SI | QUETIAPINE | 111974-69-7 | QUETIAPINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-5944-1 | 63629594401 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-5944-1) | 2025-06-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| QUETIAPINE | Bryant Ranch Prepack | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |