Quetiapine Fumarate ER
- Product NDC
- 72189-586
- 11-digit product format
- 721890586
- Labeler code
- 72189
- Product ID
- 72189-586_23820efc-4df8-9dc9-e063-6394a90a0bb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate ER
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_rx
- Application
- ANDA209635
- Marketing category
- ANDA
- Marketing start
- 2024-10-02
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-586-30 | 72189058630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-586-30) | 2024-10-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate ER | Direct_rx | 2024-10-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |