Quetiapine
- Product NDC
- 0615-8119
- 11-digit product format
- 006158119
- Labeler code
- 0615
- Product ID
- 0615-8119_9e6e2f9b-95f2-4f6f-a68d-4f67efbdea5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA202152
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8119-39 | 00615811939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8119-39) | 2018-11-07 | 0000-00-00 | No | No | Current |