fluvoxamine maleate
- Product NDC
- 62559-159
- 11-digit product format
- 625590159
- Labeler code
- 62559
- Product ID
- 62559-159_cfb2098d-d30b-4a8e-84c1-aeb8065b519c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluvoxamine maleate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA021519
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2011-08-09
- 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
- 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 | 50 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 |
|---|
| 62559-159-01 | fluvoxamine maleate | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUVOXAMINE MALEATE | ACTIVE INGREDIENT | 5LGN83G74V | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| FLUVOXAMINE | ACTIVE MOIETY | O4L1XPO44W | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 5 | |
| FLUVOXAMINE MALEATE | ACTIVE INGREDIENT | 5LGN83G74V | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FLUVOXAMINE | ACTIVE MOIETY | O4L1XPO44W | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-159 | FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20230823_7ecd83ec-88f5-4f85-9cc2-9068375d8820.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 |
|---|
| 62559-159-01 | 62559015901 | 100 TABLET, COATED in 1 BOTTLE (62559-159-01) | 2011-08-09 | 0000-00-00 | No | No | Current |