fluvoxamine maleate

Generic: fluvoxamine maleate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvoxamine maleate
Generic Name fluvoxamine maleate
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fluvoxamine maleate 100 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-064
Product ID 31722-064_3d922dc6-629d-73e8-e063-6294a90a7d09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217024
Listing Expiration 2026-12-31
Marketing Start 2025-07-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722064
Hyphenated Format 31722-064

Supplemental Identifiers

RxCUI
903873 903879
UPC
0331722064309
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 ANDA217024 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-01)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-30)
source: ndc

Packages (2)

31722-064-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-01) 31722-064-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-30)

Ingredients (1)

fluvoxamine maleate (100 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": "3d922dc6-629d-73e8-e063-6294a90a7d09", "openfda": {"upc": ["0331722064309"], "unii": ["5LGN83G74V"], "rxcui": ["903873", "903879"], "spl_set_id": ["e5574f41-d4df-42d5-baae-b317fb7c88bf"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-01)", "package_ndc": "31722-064-01", "marketing_start_date": "20250730"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-064-30)", "package_ndc": "31722-064-30", "marketing_start_date": "20250730"}], "brand_name": "Fluvoxamine Maleate", "product_id": "31722-064_3d922dc6-629d-73e8-e063-6294a90a7d09", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "31722-064", "generic_name": "Fluvoxamine Maleate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvoxamine Maleate", "active_ingredients": [{"name": "FLUVOXAMINE MALEATE", "strength": "100 mg/1"}], "application_number": "ANDA217024", "marketing_category": "ANDA", "marketing_start_date": "20250730", "listing_expiration_date": "20261231"}