Quetiapine fumarate
- Product NDC
- 71335-2462
- 11-digit product format
- 713352462
- Labeler code
- 71335
- Product ID
- 71335-2462_d98d1381-2bb8-4dd6-a247-635ec2d2651b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2462-1 | 71335246201 | 30 TABLET in 1 BOTTLE (71335-2462-1) | 30 tablet | 2024-10-01 | No | No | Historical |
| 71335-2462-2 | 71335246202 | 28 TABLET in 1 BOTTLE (71335-2462-2) | 28 tablet | 2025-02-03 | No | No | Historical |
| 71335-2462-3 | 71335246203 | 60 TABLET in 1 BOTTLE (71335-2462-3) | 60 tablet | 2024-12-13 | No | No | Historical |
| 71335-2462-4 | 71335246204 | 180 TABLET in 1 BOTTLE (71335-2462-4) | 180 tablet | 2025-02-03 | No | No | Historical |
| 71335-2462-5 | 71335246205 | 90 TABLET in 1 BOTTLE (71335-2462-5) | 90 tablet | 2024-08-01 | No | No | Historical |