Quetiapine Fumarate
- Product NDC
- 71335-1519
- 11-digit product format
- 713351519
- Labeler code
- 71335
- Product ID
- 71335-1519_33f1decc-af70-5844-e063-6294a90a2a92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 317174 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1519-1 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 105 |
| 71335-1519-2 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 105 |
| 71335-1519-3 | Quetiapine Fumarate | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 105 |
| 71335-1519-4 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 105 |
| 71335-1519-5 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1519 | QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 5 package rows | 20250502_35b2069e-209a-41ac-84e6-377d4f19be87.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 |
|---|
| 71335-1519-1 | 71335151901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1519-1) | 2020-02-20 | 0000-00-00 | No | No | Current |
| 71335-1519-2 | 71335151902 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1519-2) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1519-3 | 71335151903 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1519-3) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1519-4 | 71335151904 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1519-4) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-1519-5 | 71335151905 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1519-5) | 2024-04-03 | 0000-00-00 | No | No | Current |