Quetiapine Fumarate
- Product NDC
- 72865-269
- 11-digit product format
- 728650269
- Labeler code
- 72865
- Product ID
- 72865-269_4dc52dc1-ab22-a157-e063-6394a90a9d23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals Inc.
- Application
- ANDA204316
- Marketing category
- ANDA
- Marketing start
- 2024-02-02
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-269-01 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 72865-269-05 | Quetiapine Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 72865-269-90 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-269 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.] | 2 | Current NDC, 3 package rows | 20250328_070faf07-0ce7-4354-8643-9d222b72ecad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72865-269-01 | 72865026901 | 100 TABLET, FILM COATED in 1 BOTTLE (72865-269-01) | 2024-02-02 | No | No | Current |
| 72865-269-05 | 72865026905 | 500 TABLET, FILM COATED in 1 BOTTLE (72865-269-05) | 2024-02-02 | No | No | Current |
| 72865-269-90 | 72865026990 | 90 TABLET, FILM COATED in 1 BOTTLE (72865-269-90) | 2024-07-22 | No | No | Current |