NDC 67857-812

TOSYMRA

Sumatriptan

TOSYMRA is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Promius Pharma, Llc.. The primary component is Sumatriptan.

• Product ID: 67857-812_cb524718-e675-acbc-5250-09a04d10c214
• NDC: 67857-812
• Product Type: Human Prescription Drug
• Proprietary Name: TOSYMRA
• Generic Name: Sumatriptan
• Dosage Form: Spray
• Route of Administration: NASAL
• Marketing Start Date: 2019-07-08
• Marketing Category: NDA / NDA
• Application Number: NDA210884
• Labeler Name: Promius Pharma, LLC.
• Substance Name: SUMATRIPTAN
• Active Ingredient Strength: 10 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 67857-812-61

6 BLISTER PACK in 1 CARTON (67857-812-61) > 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (67857-812-62) > .1 SPRAY in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67857-812-62 [67857081262]

TOSYMRA SPRAY

• Marketing Category: NDA
• Application Number: NDA210884
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-08

NDC 67857-812-61 [67857081261]

TOSYMRA SPRAY

• Marketing Category: NDA
• Application Number: NDA210884
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-08

Drug Details

Active Ingredients

Ingredient	Strength
SUMATRIPTAN	10 mg/1

OpenFDA Data

• SPL SET ID: 7260d567-3824-230d-836d-8065302baaec
• Manufacturer:
  • Promius Pharma, LLC.
• UNII:
  • 8R78F6L9VO
• UPC Code:
  • 0367857812621

Pharmacological Class

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

NDC Crossover Matching brand name "TOSYMRA" or generic name "Sumatriptan"

NDC	Brand Name	Generic Name
0245-0812	TOSYMRA	sumatriptan
67857-812	TOSYMRA	TOSYMRA
0173-0449	IMITREX	sumatriptan
0173-0478	IMITREX	sumatriptan
0173-0479	IMITREX	sumatriptan
0173-0523	IMITREX	sumatriptan
0173-0524	IMITREX	sumatriptan
0173-0735	IMITREX	sumatriptan
0173-0736	IMITREX	sumatriptan
0173-0737	IMITREX	sumatriptan
0173-0739	IMITREX	sumatriptan
0143-9638	SUMATRIPTAN	sumatriptan
0527-1818	Sumatriptan	Sumatriptan
0527-1859	Sumatriptan	Sumatriptan
0781-6523	SUMATRIPTAN	sumatriptan
0781-6524	SUMATRIPTAN	sumatriptan