NDC 70518-2435

Myrbetriq

Mirabegron

Myrbetriq is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Mirabegron.

• Product ID: 70518-2435_97bf903f-9546-e409-e053-2a95a90acef6
• NDC: 70518-2435
• Product Type: Human Prescription Drug
• Proprietary Name: Myrbetriq
• Generic Name: Mirabegron
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-11-19
• Marketing Category: NDA / NDA
• Application Number: NDA202611
• Labeler Name: REMEDYREPACK INC.
• Substance Name: MIRABEGRON
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-2435-0

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2435-0)

• Marketing Start Date: 2019-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2435-0 [70518243500]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202611
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-19

Drug Details

Active Ingredients

Ingredient	Strength
MIRABEGRON	50 mg/1

Pharmacological Class

• beta3-Adrenergic Agonist [EPC]
• Adrenergic beta3-Agonists [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• beta3-Adrenergic Agonist [EPC]
• Adrenergic beta3-Agonists [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

NDC Crossover Matching brand name "Myrbetriq" or generic name "Mirabegron"

NDC	Brand Name	Generic Name
0469-2601	Myrbetriq	mirabegron
0469-2602	Myrbetriq	mirabegron
0469-5020	Myrbetriq	mirabegron
55154-8712	Myrbetriq	mirabegron
55154-8713	Myrbetriq	mirabegron
70518-2435	Myrbetriq	mirabegron
70518-3158	Myrbetriq	mirabegron