fluvoxamine maleate
- Product NDC
- 62559-158
- 11-digit product format
- 625590158
- Labeler code
- 62559
- Product ID
- 62559-158_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
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021519-001 | LUVOX | FLUVOXAMINE MALEATE | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 |
| N021519-002 | LUVOX | FLUVOXAMINE MALEATE | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 |
| N021519-003 | LUVOX | FLUVOXAMINE MALEATE | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021519-001 | AB |
| N021519-002 | AB |
| N021519-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-002 | LUVOX | 50MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-003 | LUVOX | 100MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021519-001 | LUVOX | 25MG | TABLET / ORAL | AB | RLD | 2007-12-20 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021519-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021519-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021519-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021519-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021519-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021519-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021519-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021519-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021519-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021519-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021519-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021519-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021519-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021519-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021519-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021519-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fluvoxamine maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUVOXAMINE MALEATE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5LGN83G74V | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cf9608ac-e3cb-2ff5-9afb-dc9a0d25234d | Product name | 3 | 20250515 |
| 0b12fd59-0eda-41d5-8618-6195bcd36a86 | Product name | 1 | 20250114 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62559-158-01 | fluvoxamine maleate | 100 in 1 BOTTLE | TABLET, COATED | 100 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62559-158-01 | EA - Each | 62559-158 | 7d0a3773-c2f2-4136-82b9-f12bf0e7785c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fluvoxamine maleate | FLUVOXAMINE MALEATE | REMEDYREPACK INC. | 5198b1c8-8dd6-4b8f-bd85-294ac468af53 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 021519 NDA021519 |
| fluvoxamine maleate | FLUVOXAMINE MALEATE | Preferred Pharmaceuticals, Inc. | b5b2128d-2363-4966-971f-83219755ecd7 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 021519 NDA021519 |
| fluvoxamine maleate | FLUVOXAMINE MALEATE | REMEDYREPACK INC. | 88b5207a-d87b-4541-ac6b-aa1c51715fcf | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 021519 NDA021519 |
| fluvoxamine maleate | FLUVOXAMINE MALEATE | ANI Pharmaceuticals, Inc. | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 2025-08-04 | Boxed warning, Warnings, Adverse reactions | 021519 NDA021519 62559-158 |
| fluvoxamine maleate | FLUVOXAMINE MALEATE | A-S Medication Solutions | ddc9e7e8-f041-43bb-970b-cd4b30367637 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 021519 NDA021519 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 903884 | fluvoxaMINE maleate 100 MG Oral Tablet | PSN | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
| 903887 | fluvoxaMINE maleate 25 MG Oral Tablet | PSN | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
| 903891 | fluvoxaMINE maleate 50 MG Oral Tablet | PSN | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
| 903884 | fluvoxamine maleate 100 MG Oral Tablet | SCD | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
| 903887 | fluvoxamine maleate 25 MG Oral Tablet | SCD | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
| 903891 | fluvoxamine maleate 50 MG Oral Tablet | SCD | 7ecd83ec-88f5-4f85-9cc2-9068375d8820 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62559-158-01 | 62559015801 | 100 TABLET, COATED in 1 BOTTLE (62559-158-01) | 2011-08-09 | 0000-00-00 | No | No | Current |