QUETIAPINE FUMARATE
- Product NDC
- 68001-515
- 11-digit product format
- 680010515
- Labeler code
- 68001
- Product ID
- 68001-515_e17da200-0b22-7fcb-e053-2995a90a6c42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- QUETIAPINE FUMARATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bluepoint Laboratories
- Application
- ANDA090681
- Marketing category
- ANDA
- Marketing start
- 2021-08-31
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-515 | QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES] | 3 | Legacy NDC | 20250322_0df19623-5cd5-4544-b02a-84ec7fddf87d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68001-515-06 | 68001051506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-515-06) | 2021-08-31 | 0000-00-00 | No | No | Current |