Quetiapine fumarate
- Product NDC
- 50090-6812
- 11-digit product format
- 500906812
- Labeler code
- 50090
- Product ID
- 50090-6812_adaa2388-4f2b-4e69-b476-bf10c648e372
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine fumarate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6812-0 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 50090-6812-1 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6812 | QUETIAPINE FUMARATE TABLET [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20231115_aeff3ab1-24ff-417a-8bbc-2ffa413dcb87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6812-0 | 50090681200 | 30 TABLET in 1 BOTTLE (50090-6812-0) | 30 tablet | 2023-11-08 | No | No | Historical |
| 50090-6812-1 | 50090681201 | 90 TABLET in 1 BOTTLE (50090-6812-1) | 90 tablet | 2023-11-08 | No | No | Historical |