FDA.reportPublic FDA data

Fetzima

Product NDC
0456-2280
11-digit product format
004562280
Labeler code
0456
Product ID
0456-2280_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOMILNACIPRAN HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA204168
Marketing category
NDA
Marketing start
2013-07-25
Substance
LEVOMILNACIPRAN HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fetzima
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMILNACIPRAN HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii371U2ZK31U
Rxcui1433217, 1433223, 1433227, 1433229, 1433233, 1433235, 1433239, 1433241, 1433249, 1433250, 2636817, 2636818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7efbf4fa-913e-470a-89c4-2a84490ad12aProduct name420240320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-2280-30Fetzima30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3033
0456-2280-90Fetzima90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-2280-30EA - Each0456-22805dab3f85-9315-438d-81b3-6155bbf2084512013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOMILNACIPRAN HYDROCHLORIDEACTIVE INGREDIENT371U2ZK31UFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
levomilnacipranACTIVE MOIETYUGM0326TXXFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
povidoneINACTIVE INGREDIENTFZ989GH94EFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
shellacINACTIVE INGREDIENT46N107B71OFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
talcINACTIVE INGREDIENT7SEV7J4R1UFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMFETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-2280FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.]31Current NDC, Legacy NDC, 2 package rows20240502_f371258d-91b3-4b6a-ac99-434a1964c3af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433250{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Pack]BPCKf371258d-91b3-4b6a-ac99-434a1964c3af33
2636818{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]) } Pack [Fetzima Titration Sample Pack]BPCKf371258d-91b3-4b6a-ac99-434a1964c3af33
1433249{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 26 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } PackGPCKf371258d-91b3-4b6a-ac99-434a1964c3af33
2636817{2 (24 HR levomilnacipran 20 MG Extended Release Oral Capsule) / 5 (24 HR levomilnacipran 40 MG Extended Release Oral Capsule) } PackGPCKf371258d-91b3-4b6a-ac99-434a1964c3af33
1433223Fetzima 120 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433229Fetzima 20 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433235Fetzima 40 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433241Fetzima 80 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433250Fetzima Titration Pack, 20 MG (2), 40 MG (26)PSNf371258d-91b3-4b6a-ac99-434a1964c3af33
2636818Fetzima Titration Sample Pack, 20 MG (2), 40 MG (5)PSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433217levomilnacipran 120 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433227levomilnacipran 20 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433249levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) PackPSNf371258d-91b3-4b6a-ac99-434a1964c3af33
2636817levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) PackPSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433233levomilnacipran 40 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
1433239levomilnacipran 80 MG 24HR Extended Release Oral CapsulePSNf371258d-91b3-4b6a-ac99-434a1964c3af33
143322324 HR levomilnacipran 120 MG Extended Release Oral Capsule [Fetzima]SBDf371258d-91b3-4b6a-ac99-434a1964c3af33
143322924 HR levomilnacipran 20 MG Extended Release Oral Capsule [Fetzima]SBDf371258d-91b3-4b6a-ac99-434a1964c3af33
143323524 HR levomilnacipran 40 MG Extended Release Oral Capsule [Fetzima]SBDf371258d-91b3-4b6a-ac99-434a1964c3af33
143324124 HR levomilnacipran 80 MG Extended Release Oral Capsule [Fetzima]SBDf371258d-91b3-4b6a-ac99-434a1964c3af33
143321724 HR levomilnacipran 120 MG Extended Release Oral CapsuleSCDf371258d-91b3-4b6a-ac99-434a1964c3af33
143322724 HR levomilnacipran 20 MG Extended Release Oral CapsuleSCDf371258d-91b3-4b6a-ac99-434a1964c3af33
143323324 HR levomilnacipran 40 MG Extended Release Oral CapsuleSCDf371258d-91b3-4b6a-ac99-434a1964c3af33
143323924 HR levomilnacipran 80 MG Extended Release Oral CapsuleSCDf371258d-91b3-4b6a-ac99-434a1964c3af33
143322324 HR Fetzima 120 MG Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
143322924 HR Fetzima 20 MG Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
143323524 HR Fetzima 40 MG Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
143324124 HR Fetzima 80 MG Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433223Fetzima (levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG)) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433229Fetzima (levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG)) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433235Fetzima (levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG)) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433241Fetzima (levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG)) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433223Fetzima 120 MG 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433229Fetzima 20 MG 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433235Fetzima 40 MG 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433241Fetzima 80 MG 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433250Fetzima Titration PackSYf371258d-91b3-4b6a-ac99-434a1964c3af33
2636818Fetzima Titration Sample PackSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433217levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433227levomilnacipran 20 MG (as levomilnacipran hydrochloride 23 MG) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433249levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (26) Pack (Capsule)SYf371258d-91b3-4b6a-ac99-434a1964c3af33
2636817levomilnacipran 20 MG 24HR Extended Release Oral Capsule (2) / levomilnacipran 40 MG 24HR Extended Release Oral Capsule (5) PackSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433233levomilnacipran 40 MG (as levomilnacipran hydrochloride 45.9 MG) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433233levomilnacipran 40 MG 24HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433239levomilnacipran 80 MG (as levomilnacipran hydrochloride 91.8 MG) 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33
1433239levomilnacipran 80 MG 24 HR Extended Release Oral CapsuleSYf371258d-91b3-4b6a-ac99-434a1964c3af33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0456-2280-300045622803030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-30) 2013-07-250000-00-00NoNoCurrent
0456-2280-900045622809090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-90) 2013-07-250000-00-00NoNoCurrent