Quetiapine Fumarate
- Product NDC
- 0406-1182
- 11-digit product format
- 004061182
- Labeler code
- 0406
- Product ID
- 0406-1182_9bca76f4-2922-4b22-a6f6-d65a10dc6a84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA202939
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0406-1182-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4812-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS. QUETIAPINE FUMARATE extended-release tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-1182-60 | Quetiapine FumarateExtended-Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-1182-60 | EA - Each | 0406-1182 | 6bf2213b-5f46-4401-addd-ca4eadf2f232 | 1 | 2017-06-15 |
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 | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | 24 HR quetiapine 150 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | 24 HR quetiapine 200 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | 24 HR quetiapine 400 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | 24 HR quetiapine 50 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | quetiapine 150 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | quetiapine 200 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | quetiapine 50 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0406-1182-60 | 00406118260 | 60 in 1 BOTTLE | Historical |