Fluvoxamine maleate
- Product NDC
- 68788-4011
- 11-digit product format
- 687884011
- Labeler code
- 68788
- Product ID
- 68788-4011_642b7b5e-9f1c-479b-b9b3-bf06774f7b60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvoxamine maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217917
- Marketing category
- ANDA
- Marketing start
- 2025-09-04
- Substance
- FLUVOXAMINE MALEATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluvoxamine maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUVOXAMINE MALEATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5LGN83G74V |
| Rxcui | 903884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-4011-3 | Fluvoxamine maleate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 68788-4011-6 | Fluvoxamine maleate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 68788-4011-9 | Fluvoxamine maleate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4011-3 | 68788401103 | 30 TABLET in 1 BOTTLE (68788-4011-3) | 30 tablet | 2025-09-04 | No | No | Historical |
| 68788-4011-6 | 68788401106 | 60 TABLET in 1 BOTTLE (68788-4011-6) | 60 tablet | 2025-09-04 | No | No | Historical |
| 68788-4011-9 | 68788401109 | 90 TABLET in 1 BOTTLE (68788-4011-9) | 90 tablet | 2025-09-04 | No | No | Historical |