NDC 50458-210

AXERT

Almotriptan Malate

AXERT is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Almotriptan Malate.

• Product ID: 50458-210_33016f86-638b-11ea-802d-5119fc2ca371
• NDC: 50458-210
• Product Type: Human Prescription Drug
• Proprietary Name: AXERT
• Generic Name: Almotriptan Malate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2001-05-07
• Marketing End Date: 2024-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA021001
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: ALMOTRIPTAN MALATE
• Active Ingredient Strength: 13 mg/1
• Pharm Classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 50458-210-01

12 TABLET, COATED in 1 BLISTER PACK (50458-210-01)

• Marketing Start Date: 2001-05-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-210-01 [50458021001]

AXERT TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA021001
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-05-07
• Marketing End Date: 2019-07-31

Drug Details

Active Ingredients

Ingredient	Strength
ALMOTRIPTAN MALATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: a8479ec0-204e-11e1-aa3f-a3c74724019b
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • PJP312605E
• RxNorm Concept Unique ID - RxCUI:
  • 284589
  • 284588
  • 284204
  • 284205

Pharmacological Class

• Serotonin 1d Receptor Agonists [MoA]
• Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
• Serotonin 1b Receptor Agonists [MoA]

Medicade Reported Pricing

50458021001 AXERT 12.5 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "AXERT" or generic name "Almotriptan Malate"

NDC	Brand Name	Generic Name
50458-210	AXERT	almotriptan malate
50458-211	AXERT	almotriptan malate
0093-5260	Almotriptan Malate	Almotriptan Malate
0093-5261	Almotriptan Malate	Almotriptan Malate