Quetiapine fumarate
- Product NDC
- 33342-104
- 11-digit product format
- 333420104
- Labeler code
- 33342
- Product ID
- 33342-104_e8676630-c511-427b-af62-969f338d96cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA203359
- Marketing category
- ANDA
- Marketing start
- 2016-06-14
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 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 | 300 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 |
|---|
| 33342-104-09 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 33342-104-15 | Quetiapine fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 33342-104-39 | Quetiapine fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 33342-104-39 | Quetiapine fumarate | 9 in 1 CARTON | TABLET, FILM COATED | 9 | | 9 |
| 33342-104-44 | Quetiapine fumarate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-104 | QUETIAPINE FUMARATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 9 | Current NDC, Legacy NDC, 5 package rows | 20230405_531cbe20-dff2-4983-9788-4543079f83ff.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 |
|---|
| 33342-104-09 | 33342010409 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-104-09) | | 2016-06-14 | 0000-00-00 | No | No | Current |
| 33342-104-15 | 33342010415 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-104-15) | | 2016-06-14 | 0000-00-00 | No | No | Current |
| 33342-104-39 | 33342010439 | 9 BLISTER PACK in 1 CARTON (33342-104-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 9 blister pack | 2016-06-14 | 0000-00-00 | No | No | Current |
| 33342-104-44 | 33342010444 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-104-44) | | 2016-06-14 | 0000-00-00 | No | No | Current |