Quetiapine Fumarate
- Product NDC
- 50090-3342
- 11-digit product format
- 500903342
- Labeler code
- 50090
- Product ID
- 50090-3342_79b326e6-2b92-429e-accc-361128c6dec3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3342-0 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET | 60 | | 20 |
| 50090-3342-1 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3342 | QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS] | 20 | Current NDC, Legacy NDC, 2 package rows | 20241222_132a2483-7e49-4b0c-9db4-e6e578697fd9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3342-0 | 50090334200 | 60 TABLET in 1 BOTTLE (50090-3342-0) | 60 tablet | 2018-10-19 | 0000-00-00 | No | No | Current |
| 50090-3342-1 | 50090334201 | 30 TABLET in 1 BOTTLE (50090-3342-1) | 30 tablet | 2018-01-22 | 0000-00-00 | No | No | Current |