NDC 0456-2212

Fetzima

Levomilnacipran Hydrochloride

Fetzima is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Levomilnacipran Hydrochloride.

• Product ID: 0456-2212_3e3a5ff7-e5b3-4433-b3ad-be3345ba2ff9
• NDC: 0456-2212
• Product Type: Human Prescription Drug
• Proprietary Name: Fetzima
• Generic Name: Levomilnacipran Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-25
• Marketing Category: NDA / NDA
• Application Number: NDA204168
• Labeler Name: Allergan, Inc.
• Substance Name: LEVOMILNACIPRAN HYDROCHLORIDE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0456-2212-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)

• Marketing Start Date: 2013-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0456-2212-63 [00456221263]

Fetzima CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204168
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-25
• Marketing End Date: 2013-11-01

NDC 0456-2212-30 [00456221230]

Fetzima CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204168
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-25

NDC 0456-2212-90 [00456221290]

Fetzima CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204168
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-25

Drug Details

Active Ingredients

Ingredient	Strength
LEVOMILNACIPRAN HYDROCHLORIDE	120 mg/1

OpenFDA Data

• SPL SET ID: f371258d-91b3-4b6a-ac99-434a1964c3af
• Manufacturer:
  • Allergan USA, Inc.
• UNII:
  • 371U2ZK31U
• RxNorm Concept Unique ID - RxCUI:
  • 1433241
  • 1433250
  • 1433249
  • 1433235
  • 1433227
  • 1433233
  • 1433217
  • 1433223
  • 1433229
  • 1433239
• UPC Code:
  • 0304562220303
  • 0304562212308
  • 0304562240301
  • 0304562280307

Pharmacological Class

• Norepinephrine Uptake Inhibitors [MoA]
• Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
• Serotonin Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Fetzima" or generic name "Levomilnacipran Hydrochloride"

NDC	Brand Name	Generic Name
0456-2202	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE
0456-2212	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE
0456-2220	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE
0456-2240	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE
0456-2280	Fetzima	LEVOMILNACIPRAN HYDROCHLORIDE