Quetiapine Fumarate
- Product NDC
- 34908-636
- 11-digit product format
- 349080636
- Labeler code
- 34908
- Product ID
- 34908-636_781f6242-bc94-424b-be23-ea9eb61c0889
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Novast Laboratories, Ltd.
- Application
- ANDA208947
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- 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 Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 150 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 34908-636-10 | 34908063610 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-10) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-636-30 | 34908063630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-30) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-636-60 | 34908063660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-60) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-636-90 | 34908063690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-90) | 2017-08-31 | 0000-00-00 | No | No | Current |