Quetiapine Fumarate
- Product NDC
- 50742-635
- 11-digit product format
- 507420635
- Labeler code
- 50742
- Product ID
- 50742-635_57efb2c4-97c7-4f4b-8e1f-e73ec6d6c176
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA208947
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 50 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 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 21205abd-8c89-4943-9f85-908f3d4fc3bb | Product name | 5 | 20230501 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50742-635-10 | Quetiapine Fumarate | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 13 | |
| 50742-635-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 13 | |
| 50742-635-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 13 | |
| 50742-635-90 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 13 |
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 | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721791 | QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet | PSN | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721796 | QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet | PSN | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 853201 | QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet | PSN | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 895670 | 24 HR quetiapine 150 MG Extended Release Oral Tablet | SCD | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721791 | 24 HR quetiapine 200 MG Extended Release Oral Tablet | SCD | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721796 | 24 HR quetiapine 400 MG Extended Release Oral Tablet | SCD | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 853201 | 24 HR quetiapine 50 MG Extended Release Oral Tablet | SCD | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 895670 | quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 895670 | quetiapine 150 MG 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721791 | quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721791 | quetiapine 200 MG 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 721796 | quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 853201 | quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
| 853201 | quetiapine 50 MG 24 HR Extended Release Oral Tablet | SY | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50742-635-10 | 50742063510 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-10) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 50742-635-30 | 50742063530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-30) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 50742-635-60 | 50742063560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-60) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 50742-635-90 | 50742063590 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-90) | 2017-08-31 | 0000-00-00 | No | No | Current |