NDC 13668-581

TADALAFIL

Tadalafil

TADALAFIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Tadalafil.

• Product ID: 13668-581_6827bccd-e1c0-4a74-9be4-b3adc27d2879
• NDC: 13668-581
• Product Type: Human Prescription Drug
• Proprietary Name: TADALAFIL
• Generic Name: Tadalafil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA212062
• Labeler Name: Torrent Pharmaceuticals Limited
• 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: 2020-12-31

Packaging

NDC 13668-581-05

500 TABLET in 1 BOTTLE (13668-581-05)

• Marketing Start Date: 2019-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13668-581-30 [13668058130]

TADALAFIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA212062
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-26

NDC 13668-581-71 [13668058171]

TADALAFIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA212062
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-26

NDC 13668-581-05 [13668058105]

TADALAFIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA212062
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-26

NDC 13668-581-74 [13668058174]

TADALAFIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA212062
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-26

Drug Details

Active Ingredients

Ingredient	Strength
TADALAFIL	20 mg/1

OpenFDA Data

• SPL SET ID: 88132351-7fee-47ef-8007-ef2777543299
• Manufacturer:
  • Torrent Pharmaceuticals Limited
• UNII:
  • 742SXX0ICT
• RxNorm Concept Unique ID - RxCUI:
  • 402019

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