Quetiapine Fumarate
- Product NDC
- 80425-0184
- 11-digit product format
- 804250184
- Labeler code
- 80425
- Product ID
- 80425-0184_2a99a670-af36-299d-e063-6294a90a05d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA202674
- Marketing category
- ANDA
- Marketing start
- 2016-07-01
- 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 | 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0184-3 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0184 | QUETIAPINE FUMARATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250101_d323b6c0-55fa-6caa-e053-2a95a90a3cff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0184-3 | 80425018403 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0184-3) | 2016-07-01 | 0000-00-00 | No | No | Current |