Quetiapine Fumarate
- Product NDC
- 70518-2175
- 11-digit product format
- 705182175
- Labeler code
- 70518
- Product ID
- 70518-2175_49dabae4-2161-a05a-e063-6394a90a73d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202674
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2175-0 | Quetiapine Fumarate | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2175 | QUETIAPINE FUMARATE TABLET, FILM COATED [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250508_479c9555-5d1e-4e5c-bfde-f3812829edd8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-2175-0 | 70518217500 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2175-0) | 2019-07-01 | No | No | Current |