Quetiapine Fumarate
- Product NDC
- 65862-877
- 11-digit product format
- 658620877
- Labeler code
- 65862
- Product ID
- 65862-877_631d518f-bb71-4848-98a6-f9335dc5b33b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207655
- Marketing category
- ANDA
- Marketing start
- 2017-11-29
- 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 |
|---|---|
| QUETIAPINE FUMARATE | 400 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 721791, 721794, 721796, 853201, 895670 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ef42f82-f087-0d2c-105f-f791ca69210e | Product name | 8 | 20250729 |
| 21205abd-8c89-4943-9f85-908f3d4fc3bb | Product name | 5 | 20230501 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-877-01 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 15 | |
| 65862-877-05 | Quetiapine Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | 15 | |
| 65862-877-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-877-60 | EA - Each | 65862-877 | 6bf2bb2f-ec1f-498d-a2e0-27e9470b0cee | 1 | 2017-12-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 895670 | QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet | PSN | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721791 | QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet | PSN | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721796 | QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet | PSN | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 853201 | QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet | PSN | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 895670 | 24 HR quetiapine 150 MG Extended Release Oral Tablet | SCD | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721791 | 24 HR quetiapine 200 MG Extended Release Oral Tablet | SCD | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721796 | 24 HR quetiapine 400 MG Extended Release Oral Tablet | SCD | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 853201 | 24 HR quetiapine 50 MG Extended Release Oral Tablet | SCD | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 895670 | quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 895670 | quetiapine 150 MG 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721791 | quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721791 | quetiapine 200 MG 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 721796 | quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 853201 | quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
| 853201 | quetiapine 50 MG 24 HR Extended Release Oral Tablet | SY | 6562eb60-0d70-4909-bd07-88d5c9241516 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-877-01 | 65862087701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-877-01) | 2017-11-29 | 0000-00-00 | No | No | Current |
| 65862-877-05 | 65862087705 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-877-05) | 2017-11-29 | 0000-00-00 | No | No | Current |
| 65862-877-60 | 65862087760 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-877-60) | 2017-11-29 | 0000-00-00 | No | No | Current |