Quetiapine Fumarate
- Product NDC
- 71610-140
- 11-digit product format
- 716100140
- Labeler code
- 71610
- Product ID
- 71610-140_2ddf4cb0-6d16-49fa-9267-274ed1643e90
- 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
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-140-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71610-140-53 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71610-140-60 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-140 | QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20211016_60316ccd-c042-4ea0-9d05-3caf7cc2cab1.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 |
|---|
| 71610-140-30 | 71610014030 | 30 TABLET in 1 BOTTLE (71610-140-30) | 30 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |
| 71610-140-53 | 71610014053 | 60 TABLET in 1 BOTTLE (71610-140-53) | 60 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |
| 71610-140-60 | 71610014060 | 90 TABLET in 1 BOTTLE (71610-140-60) | 90 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |