Quetiapine fumarate
- Product NDC
- 70518-2102
- 11-digit product format
- 705182102
- Labeler code
- 70518
- Product ID
- 70518-2102_499e2334-fe21-ed75-e063-6294a90a3e4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2019-05-22
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2102-0 | Quetiapine fumarate | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
| 70518-2102-1 | Quetiapine fumarate | 30 in 1 BLISTER PACK | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2102 | QUETIAPINE FUMARATE TABLET [REMEDYREPACK INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250502_ea9b9ed1-4be0-4dc0-b1dd-239caff5253e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2102-0 | 70518210200 | 30 TABLET in 1 BLISTER PACK (70518-2102-0) | 30 tablet | 2019-05-22 | 0000-00-00 | No | No | Current |
| 70518-2102-1 | 70518210201 | 30 TABLET in 1 BLISTER PACK (70518-2102-1) | 30 tablet | 2022-08-22 | 0000-00-00 | No | No | Current |