Quetiapine Fumarate
- Product NDC
- 0615-8471
- 11-digit product format
- 006158471
- Labeler code
- 0615
- Product ID
- 0615-8471_9f55185f-8471-4477-97b2-b61dd50c8b44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA202674
- Marketing category
- ANDA
- Marketing start
- 2016-07-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8471-05 | Quetiapine Fumarate | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 20 |
| 0615-8471-28 | Quetiapine Fumarate | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 20 |
| 0615-8471-30 | Quetiapine Fumarate | 6 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 6 | | 20 |
| 0615-8471-30 | Quetiapine Fumarate | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | | 20 |
| 0615-8471-39 | Quetiapine Fumarate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8471 | QUETIAPINE FUMARATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 20 | Current NDC, 5 package rows | 20250302_d73655d3-4b3f-40b4-92cb-053ad4f21a92.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8471-05 | 00615847105 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8471-05) | 2023-05-09 | No | No | Historical |
| 0615-8471-28 | 00615847128 | 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8471-28) | 2024-05-06 | No | No | Historical |
| 0615-8471-30 | 00615847130 | 6 in 1 BOX, UNIT-DOSE | | | | Historical |
| 0615-8471-39 | 00615847139 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8471-39) | 2023-05-09 | No | No | Historical |