Quetiapine Fumarate
- Product NDC
- 31722-765
- 11-digit product format
- 317220765
- Labeler code
- 31722
- Product ID
- 31722-765_6c68f74f-289f-4d3a-a0a7-ad6173b6628c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204316
- Marketing category
- ANDA
- Marketing start
- 2022-06-16
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-765-01 | Quetiapine Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 31722-765-05 | Quetiapine Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 31722-765-31 | Quetiapine Fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 31722-765-32 | Quetiapine Fumarate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 4 |
| 31722-765-33 | Quetiapine Fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 31722-765-34 | Quetiapine Fumarate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-765 | QUETIAPINE FUMARATE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 6 package rows | 20250410_5c6aeb85-3ac2-4448-b544-9a4c5f562ed3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-765-01 | 31722076501 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-765-01) | | 2022-06-16 | 0000-00-00 | No | No | Current |
| 31722-765-05 | 31722076505 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-765-05) | | 2022-06-16 | 0000-00-00 | No | No | Current |
| 31722-765-31 | 31722076531 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 31722-765-32 | 31722076532 | 100 BLISTER PACK in 1 CARTON (31722-765-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-765-31) | 100 blister pack | 2022-06-16 | 0000-00-00 | No | No | Current |
| 31722-765-33 | 31722076533 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 31722-765-34 | 31722076534 | 100 BLISTER PACK in 1 CARTON (31722-765-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-765-33) | 100 blister pack | 2022-06-16 | 0000-00-00 | No | No | Current |