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 KIT
Routes
ORAL
Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-2200
Product ID 0456-2200_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204168
Listing Expiration 2027-12-31
Marketing Start 2023-03-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04562200
Hyphenated Format 0456-2200

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
  • 40 mg
  • 80 mg
  • 120 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00)
source: ndc

Packages (1)

0456-2200-07 1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00)

Ingredients (0)

No ingredient records.

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": "1 BLISTER PACK in 1 CARTON (0456-2200-07)  / 1 KIT in 1 BLISTER PACK (0456-2200-65)  *  2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00)  *  5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00)", "package_ndc": "0456-2200-07", "marketing_start_date": "20230324"}], "brand_name": "Fetzima", "product_id": "0456-2200_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57", "dosage_form": "KIT", "product_ndc": "0456-2200", "generic_name": "LEVOMILNACIPRAN HYDROCHLORIDE", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fetzima", "application_number": "NDA204168", "marketing_category": "NDA", "marketing_start_date": "20230324", "listing_expiration_date": "20271231"}