Quetiapine Fumarate
- Product NDC
- 70518-3609
- 11-digit product format
- 705183609
- Labeler code
- 70518
- Product ID
- 70518-3609_4f6b0b54-8dd0-9d7b-e063-6294a90a44fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2023-01-04
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312745 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3609-0 | Quetiapine Fumarate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 7 |
| 70518-3609-1 | Quetiapine Fumarate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3609 | QUETIAPINE FUMARATE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241122_da5c118f-404c-4453-aa10-a8656b1d7501.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 |
|---|
| 70518-3609-0 | 70518360900 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3609-0) | 2023-01-04 | 0000-00-00 | No | No | Current |
| 70518-3609-1 | 70518360901 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3609-1) | 2025-10-16 | | No | No | Historical |