Fluvoxamine maleate
- Product NDC
- 69452-287
- 11-digit product format
- 694520287
- Labeler code
- 69452
- Product ID
- 69452-287_2fa05c01-e84f-99b2-e063-6394a90af57f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvoxamine maleate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA217917
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- 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 |
|---|
| 69452-287-20 | Fluvoxamine maleate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-287 | FLUVOXAMINE MALEATE TABLET, FILM COATED FLUVOXAMINE MALEATE TABLET [BIONPHARMA INC.] | 2 | Current NDC, 1 package rows | 20250308_191912e6-b3c8-be1a-e063-6394a90a8dd4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-287-20 | 69452028720 | 100 TABLET, FILM COATED in 1 BOTTLE (69452-287-20) | 2024-05-23 | No | No | Current |