Quetiapine fumarate
- Product NDC
- 82009-095
- 11-digit product format
- 820090095
- Labeler code
- 82009
- Product ID
- 82009-095_1d987a53-99fe-4716-99ba-ce7b86c58b73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2023-07-14
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine fumarate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 317174, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-095-01 | Quetiapine fumarate | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-095 | QUETIAPINE FUMARATE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, 1 package rows | 20250316_d51c5bf6-950d-493b-be55-de575c5ef2e7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-095-01 | 82009009501 | 100 TABLET in 1 BOTTLE (82009-095-01) | 100 tablet | 2023-07-14 | No | No | Current |