NDC 43353-070

ADCIRCA

Tadalafil

ADCIRCA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Tadalafil.

• Product ID: 43353-070_710cf772-574e-4ecd-a8aa-34190c719115
• NDC: 43353-070
• Product Type: Human Prescription Drug
• Proprietary Name: ADCIRCA
• Generic Name: Tadalafil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA022332
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: TADALAFIL
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43353-070-12

12 TABLET in 1 BOTTLE (43353-070-12)

• Marketing Start Date: 2017-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-070-12 [43353007012]

ADCIRCA TABLET

• Marketing Category: NDA
• Application Number: NDA022332
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
TADALAFIL	20 mg/1

OpenFDA Data

• SPL SET ID: 3ca3928a-6466-4290-a228-461fa8a91735
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 742SXX0ICT
• RxNorm Concept Unique ID - RxCUI:
  • 849866
  • 402019

Pharmacological Class

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

NDC Crossover Matching brand name "ADCIRCA" or generic name "Tadalafil"

NDC	Brand Name	Generic Name
43353-070	ADCIRCA	ADCIRCA
66302-467	ADCIRCA	ADCIRCA
0093-3334	ALYQ	Tadalafil
0002-4462	Cialis	Tadalafil
0002-4463	Cialis	Tadalafil
0002-4464	Cialis	Tadalafil
0002-4465	Cialis	Tadalafil
0093-3016	Tadalafil	Tadalafil
0093-3017	Tadalafil	Tadalafil
0093-3018	Tadalafil	Tadalafil
0093-3019	Tadalafil	Tadalafil