Quetiapine
- Product NDC
- 65162-431
- 11-digit product format
- 651620431
- Labeler code
- 65162
- Product ID
- 65162-431_df485c9f-5b0b-4839-b475-e6e83930d25c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Extended-release
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA211405
- Marketing category
- ANDA
- Marketing start
- 2018-10-26
- 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 |
|---|
| 65162-431 | QUETIAPINE (QUETIAPINE EXTENDED-RELEASE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 14 | Legacy NDC | 20250309_9e759f0c-5331-475b-8bce-435931a657c5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-431-06 | 65162043106 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-431-06) | 2018-10-26 | 0000-00-00 | No | No | Current |