Quetiapine Fumarate
- Product NDC
- 71205-031
- 11-digit product format
- 712050031
- Labeler code
- 71205
- Product ID
- 71205-031_013ee364-8c04-4e34-9787-834504e94c72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 616483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-031-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71205-031-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 71205-031-90 | 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 |
|---|
| 71205-031 | QUETIAPINE FUMARATE TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191101_03517f29-f270-4350-a57a-fbe1967b0096.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 |
|---|
| 71205-031-30 | 71205003130 | 30 TABLET in 1 BOTTLE (71205-031-30) | 30 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 71205-031-60 | 71205003160 | 60 TABLET in 1 BOTTLE (71205-031-60) | 60 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 71205-031-90 | 71205003190 | 90 TABLET in 1 BOTTLE (71205-031-90) | 90 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |