Quetiapine
- Product NDC
- 70518-4451
- 11-digit product format
- 705184451
- Labeler code
- 70518
- Product ID
- 70518-4451_3ccf2a84-2a35-4fc2-e063-6294a90a84f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2025-08-20
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 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 |
|---|
| 70518-4451-0 | 70518445100 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4451-0) | 2025-08-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine | REMEDYREPACK INC. | 2025-08-20 | HUMAN PRESCRIPTION DRUG LABEL | 1 |