fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluvoxamine maleate 25 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-1670
Product ID 0832-1670_45afd276-9f2a-23cd-e063-6294a90a0991
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075888
Marketing Start 2000-11-29
Marketing End 2026-06-30

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08321670
Hyphenated Format 0832-1670

Supplemental Identifiers

RxCUI
903884 903887 903891
UNII
5LGN83G74V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluvoxamine maleate (source: ndc)
Generic Name fluvoxamine maleate (source: ndc)
Application Number ANDA075888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Fluvoxamine maleate tablets, USP, for oral administration, are available as: 25 mg: Off-white, round, biconvex, film-coated, debossed "U" over "70" on one side and plain on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1670-11 50 mg: Yellow, round, biconvex, film-coated, debossed "U" over "71" on one side and bisected on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1671-11 100 mg: Beige, round, biconvex, film-coated, debossed "U" over "672" on one side and bisected on the other side. They are supplied as: Bottles of 100 with a child-resistant closure, NDC 0832-1672-11 Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep out of reach of children.
  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label NDC 0832-1670-11 Fluvoxamine Maleate Tablets, USP 25 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label NDC 0832-1671-11 Fluvoxamine Maleate Tablets, USP 50 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label NDC 0832-1672-11 Fluvoxamine Maleate Tablets, USP 100 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
source: label

Packages (0)

No package records.

Ingredients (1)

fluvoxamine maleate (25 mg/1)

Linked Drug Pages (1)

Fluvoxamine maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45afd276-9f2a-23cd-e063-6294a90a0991", "openfda": {"unii": ["5LGN83G74V"], "rxcui": ["903884", "903887", "903891"], "spl_set_id": ["52b29024-b639-4c88-ac6c-0c64dbd204f4"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Fluvoxamine maleate", "product_id": "0832-1670_45afd276-9f2a-23cd-e063-6294a90a0991", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0832-1670", "generic_name": "Fluvoxamine maleate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "25 mg/1"}], "application_number": "ANDA075888", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20001129"}