Quetiapine fumarate
- Product NDC
- 68071-3676
- 11-digit product format
- 680713676
- Labeler code
- 68071
- Product ID
- 68071-3676_227b96be-c07d-20e7-e063-6394a90ad9ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3676-9 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3676 | QUETIAPINE FUMARATE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240922_227b8b2b-a238-efb4-e063-6394a90acc7e.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 |
|---|
| 68071-3676-9 | 68071367609 | 90 TABLET in 1 BOTTLE (68071-3676-9) | 90 tablet | 2024-09-19 | No | No | Historical |