Quetiapine Fumarate
- Product NDC
- 72189-446
- 11-digit product format
- 721890446
- Labeler code
- 72189
- Product ID
- 72189-446_4c4b8f97-e2a3-7bdf-e063-6294a90af5cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2023-03-14
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-446-30 | Quetiapine Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 72189-446-60 | Quetiapine Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-446 | QUETIAPINE FUMARATE TABLET [DIRECT_RX] | 2 | Current NDC, 2 package rows | 20250123_f6de1d2b-b10e-2e9a-e053-6394a90a735d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-446-30 | 72189044630 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-446-30) | 2023-03-14 | No | No | Current |
| 72189-446-60 | 72189044660 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-446-60) | 2023-03-14 | No | No | Current |