Quetiapine Fumarate
- Product NDC
- 71335-2394
- 11-digit product format
- 713352394
- Labeler code
- 71335
- Product ID
- 71335-2394_351feec9-208b-e74a-e063-6394a90aa399
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 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 | 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 |
|---|
| 71335-2394-1 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71335-2394-2 | Quetiapine Fumarate | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 2 |
| 71335-2394-3 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 71335-2394-4 | Quetiapine Fumarate | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
| 71335-2394-5 | Quetiapine Fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2394 | QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 2 | Current NDC, 5 package rows | 20250516_6efc2886-7dcc-4dac-a212-76078a7efaa7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2394-1 | 71335239401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2394-1) | 2024-05-29 | No | No | Historical |
| 71335-2394-2 | 71335239402 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2394-2) | 2024-05-29 | No | No | Historical |
| 71335-2394-3 | 71335239403 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2394-3) | 2024-05-29 | No | No | Historical |
| 71335-2394-4 | 71335239404 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2394-4) | 2024-05-29 | No | No | Historical |
| 71335-2394-5 | 71335239405 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2394-5) | 2024-05-29 | No | No | Historical |