NDC 0378-3140

Frovatriptan

Frovatriptan

Frovatriptan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Frovatriptan Succinate.

• Product ID: 0378-3140_9b875396-1c45-401f-9faa-8af5d9a28eb5
• NDC: 0378-3140
• Product Type: Human Prescription Drug
• Proprietary Name: Frovatriptan
• Generic Name: Frovatriptan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-29
• Marketing End Date: 2023-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202931
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: FROVATRIPTAN SUCCINATE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0378-3140-85

1 BLISTER PACK in 1 CARTON (0378-3140-85) > 9 TABLET, FILM COATED in 1 BLISTER PACK (0378-3140-32)

• Marketing Start Date: 2016-04-29
• Marketing End Date: 2023-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3140-32 [00378314032]

Frovatriptan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202931
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-29

NDC 0378-3140-85 [00378314085]

Frovatriptan TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202931
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-29

Drug Details

Active Ingredients

Ingredient	Strength
FROVATRIPTAN SUCCINATE	2.5 mg/1

OpenFDA Data

• SPL SET ID: 626483a8-a543-4183-99bd-7293767881ad
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • D28J6W18HY
• RxNorm Concept Unique ID - RxCUI:
  • 349462
• UPC Code:
  • 0303783140599

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0378-3140	Frovatriptan	frovatriptan
50742-299	FROVATRIPTAN	frovatriptan succinate
69238-1539	Frovatriptan	Frovatriptan succinate