Quetiapine
- Product NDC
- 29300-309
- 11-digit product format
- 293000309
- Labeler code
- 29300
- Product ID
- 29300-309_c5ece454-9c87-42df-a9f9-fc9806d7c312
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA215478
- Marketing category
- ANDA
- Marketing start
- 2022-08-15
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 150 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 150 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 |
|---|---|---|---|---|---|---|
| 29300-309-16 | Quetiapine | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 29300-309-16 | EA - Each | 29300-309 | af3eb839-8fb6-4736-83c2-541a3a2eadb6 | 1 | 2022-11-07 |
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 | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721791 | QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet | PSN | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721796 | QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet | PSN | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 853201 | QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet | PSN | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 895670 | 24 HR quetiapine 150 MG Extended Release Oral Tablet | SCD | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721791 | 24 HR quetiapine 200 MG Extended Release Oral Tablet | SCD | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721796 | 24 HR quetiapine 400 MG Extended Release Oral Tablet | SCD | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 853201 | 24 HR quetiapine 50 MG Extended Release Oral Tablet | SCD | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 895670 | quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 895670 | quetiapine 150 MG 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721791 | quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721791 | quetiapine 200 MG 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 721796 | quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 853201 | quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
| 853201 | quetiapine 50 MG 24 HR Extended Release Oral Tablet | SY | 61695b42-cf71-43e3-8b5d-788fd439489f | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 29300-309-16 | 29300030916 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-309-16) | 2022-09-12 | 0000-00-00 | No | No | Current |