Quetiapine Fumarate
- Product NDC
- 68788-7813
- 11-digit product format
- 687887813
- Labeler code
- 68788
- Product ID
- 68788-7813_53789440-dcb0-475b-8b86-4033a2557695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2020-10-30
- 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 |
|---|
| 68788-7813-1 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 68788-7813-3 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 68788-7813-6 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
| 68788-7813-8 | Quetiapine Fumarate | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 8 |
| 68788-7813-9 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7813 | QUETIAPINE FUMARATE TABLET [PREFERRED PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240806_717b55c4-a23f-4d74-8023-0f4e14d89ec8.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 |
|---|
| 68788-7813-1 | 68788781301 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7813-1) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 68788-7813-3 | 68788781303 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7813-3) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 68788-7813-6 | 68788781306 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7813-6) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 68788-7813-8 | 68788781308 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-7813-8) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 68788-7813-9 | 68788781309 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7813-9) | 2020-10-30 | 0000-00-00 | No | No | Current |