Quetiapine Fumarate
- Product NDC
- 71335-1562
- 11-digit product format
- 713351562
- Labeler code
- 71335
- Product ID
- 71335-1562_37b76bb8-f6d9-4a1c-9bea-e55e68ff7c0a
- 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
- 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 |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1562-1 | 71335156201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1562-1) | 2020-04-07 | 0000-00-00 | No | No | Current |
| 71335-1562-2 | 71335156202 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1562-2) | 2020-07-06 | 0000-00-00 | No | No | Current |
| 71335-1562-3 | 71335156203 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1562-3) | 2021-01-18 | 0000-00-00 | No | No | Current |
| 71335-1562-4 | 71335156204 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1562-4) | 2025-06-27 | 0000-00-00 | No | No | Current |
| 71335-1562-5 | 71335156205 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1562-5) | 2025-06-27 | | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Bryant Ranch Prepack | 2025-06-27 | HUMAN PRESCRIPTION DRUG LABEL | 107 |