Quetiapine fumarate
- Product NDC
- 71335-2422
- 11-digit product format
- 713352422
- Labeler code
- 71335
- Product ID
- 71335-2422_2c265ca9-dd7f-493f-be8b-fc9785263fbb
- 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
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2422_2c265ca9-dd7f-493f-be8b-fc9785263fbb
- SPL ID
- 2c265ca9-dd7f-493f-be8b-fc9785263fbb
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Quetiapine fumarate
- Generic name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2012-03-27
- Marketing category
- ANDA
- Application number
- ANDA201109
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 616487 |
| Spl Set Id | fd9cce28-0052-4b0b-8a66-a1615e082d95 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2422-1 | 30 TABLET in 1 BOTTLE (71335-2422-1) | 2024-07-01 | No |
| 71335-2422-2 | 60 TABLET in 1 BOTTLE (71335-2422-2) | 2024-07-01 | No |
| 71335-2422-3 | 90 TABLET in 1 BOTTLE (71335-2422-3) | 2024-07-01 | No |
| 71335-2422-4 | 25 TABLET in 1 BOTTLE (71335-2422-4) | 2024-07-01 | No |
| 71335-2422-5 | 120 TABLET in 1 BOTTLE (71335-2422-5) | 2024-07-01 | No |
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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2422-1 | 71335242201 | 30 TABLET in 1 BOTTLE (71335-2422-1) | 30 tablet | 2024-07-01 | No | No | Historical |
| 71335-2422-2 | 71335242202 | 60 TABLET in 1 BOTTLE (71335-2422-2) | 60 tablet | 2024-07-01 | No | No | Historical |
| 71335-2422-3 | 71335242203 | 90 TABLET in 1 BOTTLE (71335-2422-3) | 90 tablet | 2024-07-01 | No | No | Historical |
| 71335-2422-4 | 71335242204 | 25 TABLET in 1 BOTTLE (71335-2422-4) | 25 tablet | 2024-07-01 | No | No | Historical |
| 71335-2422-5 | 71335242205 | 120 TABLET in 1 BOTTLE (71335-2422-5) | 120 tablet | 2024-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine fumarate | Bryant Ranch Prepack | 2025-02-14 | HUMAN PRESCRIPTION DRUG LABEL | 2 |