Fluvoxamine Maleate
- Product NDC
- 62135-931
- 11-digit product format
- 621350931
- Labeler code
- 62135
- Product ID
- 62135-931_2c617129-3c30-3713-e063-6294a90af923
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvoxamine Maleate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA075900
- Marketing category
- ANDA
- Marketing start
- 2006-02-23
- Substance
- FLUVOXAMINE MALEATE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5LGN83G74V |
| Rxcui | 903884, 903887, 903891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-931-90 | Fluvoxamine Maleate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-931 | FLUVOXAMINE MALEATE TABLET, FILM COATED [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20250125_b8320308-084f-43fb-9b1d-5620a0efaf46.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-931-90 | 62135093190 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-931-90) | 2024-12-18 | No | No | Current |