Quetiapine Fumarate
- Product NDC
- 43353-011
- 11-digit product format
- 433530011
- Labeler code
- 43353
- Product ID
- 43353-011_ba04e9ec-26d0-4ec3-ba89-9443def0c189
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077745
- Marketing category
- ANDA
- Marketing start
- 2014-01-17
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 43353-011 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Legacy NDC | 20171012_14e28312-2fa3-4492-b791-1734b10a8749.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-011-15 | 43353001115 | 15 TABLET, FILM COATED in 1 BOTTLE (43353-011-15) | 2015-03-26 | 0000-00-00 | No | No | Current |
| 43353-011-30 | 43353001130 | 30 TABLET, FILM COATED in 1 BOTTLE (43353-011-30) | 2015-03-26 | 0000-00-00 | No | No | Current |
| 43353-011-60 | 43353001160 | 90 TABLET, FILM COATED in 1 BOTTLE (43353-011-60) | 2015-03-26 | 0000-00-00 | No | No | Current |