quetiapine fumarate
- Product NDC
- 43353-155
- 11-digit product format
- 433530155
- Labeler code
- 43353
- Product ID
- 43353-155_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090960
- Marketing category
- ANDA
- Marketing start
- 2015-07-21
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43353-155-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 43353-155-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 43353-155-45 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 43353-155-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 43353-155-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-155-15 | quetiapine fumarate | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 43353-155-30 | quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 43353-155-45 | quetiapine fumarate | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
| 43353-155-53 | quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 43353-155-60 | quetiapine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-155 | QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 5 package rows | 20160713_448cbd68-ab4f-447c-8e47-0f874fb5bcb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-155-15 | 43353015515 | 15 in 1 BOTTLE | Historical |
| 43353-155-30 | 43353015530 | 30 in 1 BOTTLE | Historical |
| 43353-155-45 | 43353015545 | 45 in 1 BOTTLE | Historical |
| 43353-155-53 | 43353015553 | 60 in 1 BOTTLE | Historical |
| 43353-155-60 | 43353015560 | 90 in 1 BOTTLE | Historical |