NDC 76299-321

Stendra

Avanafil

Stendra is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mist Pharmaceuticals, Llc. The primary component is Avanafil.

• Product ID: 76299-321_3e7ad8d2-412c-4253-81f1-cd542ebab45b
• NDC: 76299-321
• Product Type: Human Prescription Drug
• Proprietary Name: Stendra
• Generic Name: Avanafil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA202276
• Labeler Name: Mist Pharmaceuticals, LLC
• Substance Name: AVANAFIL
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76299-321-85

30 TABLET in 1 BOTTLE (76299-321-85)

• Marketing Start Date: 2013-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76299-321-88 [76299032188]

Stendra TABLET

• Marketing Category: NDA
• Application Number: NDA202276
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-12-27
• Inactivation Date: 2020-01-31

NDC 76299-321-96 [76299032196]

Stendra TABLET

• Marketing Category: NDA
• Application Number: NDA202276
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-01
• Inactivation Date: 2020-01-31

NDC 76299-321-01 [76299032101]

Stendra TABLET

• Marketing Category: NDA
• Application Number: NDA202276
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-01-05

NDC 76299-321-85 [76299032185]

Stendra TABLET

• Marketing Category: NDA
• Application Number: NDA202276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AVANAFIL	100 mg/1

OpenFDA Data

• SPL SET ID: a8726f90-9329-46ca-9379-2b50c78fe0e2
• Manufacturer:
  • Mist Pharmaceuticals, LLC
• UNII:
  • DR5S136IVO
• RxNorm Concept Unique ID - RxCUI:
  • 1291371
  • 1291367
  • 1291365
  • 1291369
  • 1291312
  • 1291306

Pharmacological Class

• Phosphodiesterase 5 Inhibitor [EPC]
• Phosphodiesterase 5 Inhibitors [MoA]

NDC Crossover Matching brand name "Stendra" or generic name "Avanafil"

NDC	Brand Name	Generic Name
62541-501	STENDRA	Avanafil
62541-502	STENDRA	Avanafil
62541-503	STENDRA	Avanafil
72384-751	Stendra	avanafil
72384-752	Stendra	avanafil
72384-753	Stendra	avanafil
76299-320	Stendra	avanafil
76299-321	Stendra	avanafil
76299-322	Stendra	avanafil