Quetiapine
- Product NDC
- 70518-4430
- 11-digit product format
- 705184430
- Labeler code
- 70518
- Product ID
- 70518-4430_3c2f4bb7-7928-4694-e063-6394a90a0578
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215478
- Marketing category
- ANDA
- Marketing start
- 2025-08-12
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 |
|---|
| 70518-4430-0 | 70518443000 | 60 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-0) | 2025-08-12 | No | No | Historical |
| 70518-4430-1 | 70518443001 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4430-1) | 2025-08-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine | REMEDYREPACK INC. | 2025-08-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |