Quetiapine fumarate
- Product NDC
- 71335-2157
- 11-digit product format
- 713352157
- Labeler code
- 71335
- Product ID
- 71335-2157_34f7e401-9ae3-7d63-e063-6394a90a1f00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201190
- Marketing category
- ANDA
- Marketing start
- 2012-03-28
- 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 | 317174 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2157-1 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 104 |
| 71335-2157-2 | Quetiapine fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 104 |
| 71335-2157-3 | Quetiapine fumarate | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 104 |
| 71335-2157-4 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 104 |
| 71335-2157-5 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2157 | QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 5 package rows | 20250514_c52a9bff-8a03-44f5-9128-799c7dca0467.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 |
|---|
| 71335-2157-1 | 71335215701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2157-1) | 2022-11-01 | 0000-00-00 | No | No | Current |
| 71335-2157-2 | 71335215702 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2157-2) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-2157-3 | 71335215703 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2157-3) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-2157-4 | 71335215704 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2157-4) | 2024-04-03 | 0000-00-00 | No | No | Current |
| 71335-2157-5 | 71335215705 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2157-5) | 2024-04-03 | 0000-00-00 | No | No | Current |