Quetiapine Fumarate
- Product NDC
- 72189-477
- 11-digit product format
- 721890477
- Labeler code
- 72189
- Product ID
- 72189-477_2c4e047c-e102-db6f-e063-6394a90ac37a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2023-05-30
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 616483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-477-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-477 | QUETIAPINE FUMARATE TABLET, FILM COATED [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_fceb9f47-8da7-7138-e053-6294a90a5558.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-477-30 | 72189047730 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-477-30) | 2023-05-30 | No | No | Current |