NDC 71610-214

Tadalafil

Tadalafil

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

• Product ID: 71610-214_004c75b3-29f0-4e32-82fe-fec4ce0350d3
• NDC: 71610-214
• Product Type: Human Prescription Drug
• Proprietary Name: Tadalafil
• Generic Name: Tadalafil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-27
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021368
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: TADALAFIL
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71610-214-08

8 TABLET, FILM COATED in 1 BOTTLE (71610-214-08)

• Marketing Start Date: 2018-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71610-214-08 [71610021408]

Tadalafil TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021368
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-28

NDC 71610-214-18 [71610021418]

Tadalafil TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021368
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-28

NDC 71610-214-11 [71610021411]

Tadalafil TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA021368
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-28

Drug Details

Active Ingredients

Ingredient	Strength
TADALAFIL	5 mg/1

OpenFDA Data

• SPL SET ID: 1621128d-56e9-48f0-876c-77081daa7f12
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 742SXX0ICT
• RxNorm Concept Unique ID - RxCUI:
  • 402019
  • 403957

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0093-3016	Tadalafil	Tadalafil
0093-3017	Tadalafil	Tadalafil
0093-3018	Tadalafil	Tadalafil
0093-3019	Tadalafil	Tadalafil
68180-914	Tadalafil	Tadalafil
68382-896	Tadalafil	Tadalafil
68382-898	Tadalafil	Tadalafil
68382-897	Tadalafil	Tadalafil
68382-899	Tadalafil	Tadalafil
69097-376	Tadalafil	Tadalafil
69097-375	Tadalafil	Tadalafil
69097-373	Tadalafil	Tadalafil
69097-526	Tadalafil	Tadalafil
69097-374	Tadalafil	Tadalafil
69238-1347	Tadalafil	Tadalafil
69238-1346	Tadalafil	Tadalafil
69238-1348	Tadalafil	Tadalafil
69238-1349	Tadalafil	Tadalafil
70771-1476	Tadalafil	Tadalafil
70771-1477	Tadalafil	Tadalafil
70771-1478	Tadalafil	Tadalafil
70771-1475	Tadalafil	Tadalafil
71610-214	Tadalafil	Tadalafil
71610-213	Tadalafil	Tadalafil
13668-568	TADALAFIL	TADALAFIL
13668-566	TADALAFIL	TADALAFIL
13668-567	TADALAFIL	TADALAFIL
13668-565	TADALAFIL	TADALAFIL
13668-581	TADALAFIL	TADALAFIL
16729-370	Tadalafil	Tadalafil
16729-372	Tadalafil	Tadalafil
16729-369	Tadalafil	Tadalafil
27241-123	Tadalafil	Tadalafil
27241-111	Tadalafil	Tadalafil
27241-112	Tadalafil	Tadalafil
29300-289	tadalafil	tadalafil
29300-288	tadalafil	tadalafil
27241-114	Tadalafil	Tadalafil
27241-113	Tadalafil	Tadalafil
31722-646	Tadalafil	Tadalafil
29300-286	tadalafil	tadalafil
31722-645	Tadalafil	Tadalafil
29300-287	tadalafil	tadalafil
31722-643	Tadalafil	Tadalafil
31722-647	Tadalafil	Tadalafil
31722-644	Tadalafil	Tadalafil
35573-411	Tadalafil	Tadalafil
35573-410	Tadalafil	Tadalafil
35573-412	Tadalafil	Tadalafil
35573-409	Tadalafil	Tadalafil