quetiapine fumarate
- Product NDC
- 60505-3135
- 11-digit product format
- 605053135
- Labeler code
- 60505
- Product ID
- 60505-3135_bdf36658-c472-9290-51e8-289072ae3157
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA090960
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Marketing end
- 2021-06-30
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 60505-3135-8 | 60505313508 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3135-8) | 2012-03-27 | 2021-06-30 | No | No | Current |