Quetiapine Fumarate
- Product NDC
- 43353-008
- 11-digit product format
- 433530008
- Labeler code
- 43353
- Product ID
- 43353-008_02d04e01-a007-457d-9200-990cd737611e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090120
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- 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
- 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 |
|---|
| 43353-008 | QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20170626_c26aa949-3687-4b0a-9435-d32781c1e2e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-008-18 | 43353000818 | 3000 TABLET in 1 BOTTLE (43353-008-18) | 3000 tablet | 2015-03-14 | 0000-00-00 | No | No | Current |