fluvoxamine maleate
- Product NDC
- 70518-1643
- 11-digit product format
- 705181643
- Labeler code
- 70518
- Product ID
- 70518-1643_5023bd30-d8fa-9222-e063-6394a90a59e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvoxamine maleate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA021519
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-10-07
- Substance
- FLUVOXAMINE MALEATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fluvoxamine maleate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUVOXAMINE MALEATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5LGN83G74V |
| Rxcui | 903891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-1643-0 | fluvoxamine maleate | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 16 |
| 70518-1643-1 | fluvoxamine maleate | 50 in 1 BOX | TABLET, COATED | 50 | | 16 |
| 70518-1643-2 | fluvoxamine maleate | 1 in 1 POUCH | TABLET, COATED | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1643 | FLUVOXAMINE MALEATE TABLET, COATED [REMEDYREPACK INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20250507_5198b1c8-8dd6-4b8f-bd85-294ac468af53.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 |
|---|
| 70518-1643-0 | 70518164300 | 30 TABLET, COATED in 1 BLISTER PACK (70518-1643-0) | | 2018-10-07 | 0000-00-00 | No | No | Current |
| 70518-1643-1 | 70518164301 | 50 POUCH in 1 BOX (70518-1643-1) / 1 TABLET, COATED in 1 POUCH (70518-1643-2) | 50 pouch | 2026-04-23 | | No | No | Current |
| 70518-1643-2 | 70518164302 | 1 in 1 POUCH | | | | | | Historical |