Quetiapine Fumarate
- Product NDC
- 65862-875
- 11-digit product format
- 658620875
- Labeler code
- 65862
- Product ID
- 65862-875_631d518f-bb71-4848-98a6-f9335dc5b33b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207655
- Marketing category
- ANDA
- Marketing start
- 2017-11-29
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 721791, 721794, 721796, 853201, 895670 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-875-01 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 15 |
| 65862-875-05 | Quetiapine Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 15 |
| 65862-875-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-875 | QUETIAPINE FUMARATE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 14 | Current NDC, Legacy NDC, 3 package rows | 20250225_6562eb60-0d70-4909-bd07-88d5c9241516.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-875-01 | 65862087501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-01) | 2017-11-29 | 0000-00-00 | No | No | Current |
| 65862-875-05 | 65862087505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-05) | 2017-11-29 | 0000-00-00 | No | No | Current |
| 65862-875-60 | 65862087560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-875-60) | 2017-11-29 | 0000-00-00 | No | No | Current |