Quetiapine Fumarate ER
- Product NDC
- 72189-642
- 11-digit product format
- 721890642
- Labeler code
- 72189
- Product ID
- 72189-642_3fb5c81f-ce60-98bf-e063-6294a90a5711
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate ER
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA204253
- Marketing category
- ANDA
- Marketing start
- 2025-09-26
- 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 ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 721796 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-642-30 | Quetiapine Fumarate ER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-642-30 | 72189064230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-642-30) | 2025-09-26 | No | No | Current |