Quetiapine Fumarate ER
- Product NDC
- 72189-519
- 11-digit product format
- 721890519
- Labeler code
- 72189
- Product ID
- 72189-519_2c4e7611-7a3a-f31d-e063-6394a90a236f
- 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
- 2023-11-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 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 ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 721791 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-519-30 | Quetiapine Fumarate ER | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-519 | QUETIAPINE FUMARATE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_0917ef53-2647-b54b-e063-6294a90a4211.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-519-30 | 72189051930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-519-30) | 2023-11-01 | No | No | Current |