Quetiapine Fumarate
- Product NDC
- 72189-340
- 11-digit product format
- 721890340
- Labeler code
- 72189
- Product ID
- 72189-340_2c4c665e-2c4a-1290-e063-6294a90af14b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2022-03-28
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 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 table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-340-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 72189-340-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-340 | QUETIAPINE FUMARATE TABLET [DIRECT RX] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250123_db48ec02-1119-f343-e053-2a95a90afb3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-340-30 | 72189034030 | 30 TABLET in 1 BOTTLE (72189-340-30) | 30 tablet | 2022-03-28 | | No | No | Current |
| 72189-340-60 | 72189034060 | 60 TABLET in 1 BOTTLE (72189-340-60) | 60 tablet | 2022-03-28 | 0000-00-00 | No | No | Current |