Fluvoxamine maleate
These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
52b29024-b639-4c88-ac6c-0c64dbd204f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluvoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-1670
Application NumberANDA075888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (12)
Fluvoxamine maleateActive
Quantity: 25 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
Fluvoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-1671
Application NumberANDA075888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (12)
Fluvoxamine maleateActive
Quantity: 50 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fluvoxamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-1672
Application NumberANDA075888
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluvoxamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2023
FDA Product Classification
INGREDIENTS (13)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Fluvoxamine maleateActive
Quantity: 100 mg in 1 1
Code: 5LGN83G74V
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT