Quetiapine
- Product NDC
- 70518-4051
- 11-digit product format
- 705184051
- Labeler code
- 70518
- Product ID
- 70518-4051_3fa1b7c9-0ddc-66f7-e063-6294a90a9b6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209635
- Marketing category
- ANDA
- Marketing start
- 2024-04-13
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 150 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
- Brand name suffix
- Extended Release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 895670 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4051-0 | QuetiapineExtended Release | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4051 | QUETIAPINE EXTENDED RELEASE (QUETIAPINE) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.] | 3 | Current NDC, 1 package rows | 20241207_995731f7-aace-4140-b699-d6e8975c7c83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4051-0 | 70518405100 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4051-0) | 2024-04-13 | No | No | Historical |