Quetiapine Fumarate
- Product NDC
- 71335-9627
- 11-digit product format
- 713359627
- Labeler code
- 71335
- Product ID
- 71335-9627_8d53f7c7-01b9-402f-96a2-68875e9bc630
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- 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 | 616483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-9627-1 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 103 |
| 71335-9627-2 | Quetiapine Fumarate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 103 |
| 71335-9627-3 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 103 |
| 71335-9627-4 | Quetiapine Fumarate | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 103 |
| 71335-9627-5 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9627 | QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, 5 package rows | 20240727_897184b1-de3c-4d59-91be-3069325fd5b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9627-1 | 71335962701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9627-1) | 2023-01-23 | No | No | Current |
| 71335-9627-2 | 71335962702 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9627-2) | 2026-04-15 | No | No | Current |
| 71335-9627-3 | 71335962703 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9627-3) | 2026-04-15 | No | No | Current |
| 71335-9627-4 | 71335962704 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9627-4) | 2026-04-15 | No | No | Current |
| 71335-9627-5 | 71335962705 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9627-5) | 2026-04-15 | No | No | Current |