fetzima

Generic: levomilnacipran hydrochloride

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fetzima
Generic Name levomilnacipran hydrochloride
Labeler allergan, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

levomilnacipran hydrochloride 20 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-2220
Product ID 0456-2220_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204168
Listing Expiration 2027-12-31
Marketing Start 2013-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04562220
Hyphenated Format 0456-2220

Supplemental Identifiers

RxCUI
1433217 1433223 1433227 1433229 1433233 1433235 1433239 1433241 1433249 1433250 2636817 2636818
UPC
0304562240301
UNII
371U2ZK31U

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 fetzima (source: ndc)
Generic Name levomilnacipran hydrochloride (source: ndc)
Application Number NDA204168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-07)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-30)
source: ndc

Packages (2)

0456-2220-07 40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-07) 0456-2220-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-30)

Ingredients (1)

levomilnacipran hydrochloride (20 mg/1)

Linked Drug Pages (1)

Fetzima ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4f9c587-d1eb-462b-bad2-ed0ce6d76c57", "openfda": {"upc": ["0304562240301"], "unii": ["371U2ZK31U"], "rxcui": ["1433217", "1433223", "1433227", "1433229", "1433233", "1433235", "1433239", "1433241", "1433249", "1433250", "2636817", "2636818"], "spl_set_id": ["f371258d-91b3-4b6a-ac99-434a1964c3af"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-07)", "package_ndc": "0456-2220-07", "marketing_start_date": "20130725"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-30)", "package_ndc": "0456-2220-30", "marketing_start_date": "20130725"}], "brand_name": "Fetzima", "product_id": "0456-2220_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "0456-2220", "generic_name": "LEVOMILNACIPRAN HYDROCHLORIDE", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fetzima", "active_ingredients": [{"name": "LEVOMILNACIPRAN HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "NDA204168", "marketing_category": "NDA", "marketing_start_date": "20130725", "listing_expiration_date": "20271231"}