Quetiapine
- Product NDC
- 68071-3921
- 11-digit product format
- 680713921
- Labeler code
- 68071
- Product ID
- 68071-3921_44e9af46-3b06-d8ac-e063-6394a90a6bbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA209635
- Marketing category
- ANDA
- Marketing start
- 2017-11-29
- 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 |
|---|
| 68071-3921-6 | 68071392106 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-3921-6) | 2025-12-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Extended Release | NuCare Pharmaceuticals, Inc. | 2025-12-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |