fluvoxamine maleate
- Product NDC
- 70518-1057
- 11-digit product format
- 705181057
- Labeler code
- 70518
- Product ID
- 70518-1057_484af28c-07a6-db5d-e063-6294a90acad3
- 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
- 2018-03-13
- 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
- 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 | 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 |
|---|
| 70518-1057-0 | fluvoxamine maleate | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1057 | FLUVOXAMINE MALEATE TABLET, COATED [REMEDYREPACK INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20250507_88b5207a-d87b-4541-ac6b-aa1c51715fcf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1057-0 | 70518105700 | 30 TABLET, COATED in 1 BLISTER PACK (70518-1057-0) | 2018-03-13 | 0000-00-00 | No | No | Current |