NDC 65162-455

Levomilnacipran

Levomilnacipran

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

• Product ID: 65162-455_32f4b2b4-c912-43a2-8c5b-e370352b980d
• NDC: 65162-455
• Product Type: Human Prescription Drug
• Proprietary Name: Levomilnacipran
• Generic Name: Levomilnacipran
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210790
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: LEVOMILNACIPRAN HYDROCHLORIDE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65162-455-03

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-455-03)

• Marketing Start Date: 2019-02-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-455-03 [65162045503]

Levomilnacipran CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA210790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-04

Drug Details

Active Ingredients

Ingredient	Strength
LEVOMILNACIPRAN HYDROCHLORIDE	120 mg/1

OpenFDA Data

• SPL SET ID: bcbc5d92-e022-4a0d-ab4d-2b0d7aa68c58
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • 371U2ZK31U
• RxNorm Concept Unique ID - RxCUI:
  • 1433227
  • 1433233
  • 1433239
  • 1433217
• UPC Code:
  • 0365162437034
  • 0365162960037
  • 0365162455038
  • 0365162411034

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
65162-411	Levomilnacipran	Levomilnacipran
65162-437	Levomilnacipran	Levomilnacipran
65162-455	Levomilnacipran	Levomilnacipran
65162-960	Levomilnacipran	Levomilnacipran