Quetiapine fumarate
- Product NDC
- 68071-2728
- 11-digit product format
- 680712728
- Labeler code
- 68071
- Product ID
- 68071-2728_dfb482e6-a407-c450-e053-2995a90a20b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA201190
- Marketing category
- ANDA
- Marketing start
- 2012-03-28
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2728-6 | 68071272806 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-2728-6) | 2022-05-23 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine fumarate | NuCare Pharmaceuticals,Inc. | 2022-05-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |