Quetiapine
- Product NDC
- 71335-2641
- 11-digit product format
- 713352641
- Labeler code
- 71335
- Product ID
- 71335-2641_a6ac6b04-2df1-4c0b-9e26-1db660b84d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215478
- Marketing category
- ANDA
- Marketing start
- 2022-08-15
- 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 |
|---|
| 71335-2641-1 | 71335264101 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2641-1) | 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 |