tadalafil

Product NDC: 82804-224
11-digit product format: 828040224
Labeler code: 82804
Product ID: 82804-224_7976c4ec-ecc4-4a49-a4fe-f990aece2d3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209250
Marketing category: ANDA
Marketing start: 2019-03-26
Substance: TADALAFIL
Active strength: 10 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 82804-224_7976c4ec-ecc4-4a49-a4fe-f990aece2d3c
SPL ID: 7976c4ec-ecc4-4a49-a4fe-f990aece2d3c
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: tadalafil
Generic name: tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2019-03-26
Marketing category: ANDA
Application number: ANDA209250
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC]; Phosphodiesterase 5 Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
TADALAFIL	10 mg/1

Package NDC	Description	Marketing start	Sample
82804-224-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-224-30)	2025-05-21	No
82804-224-90	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-224-90)	2025-05-21	No

UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-224-30	82804022430	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-224-30)	2025-05-21	No	No	Historical
82804-224-90	82804022490	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-224-90)	2025-05-21	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
tadalafil	Proficient Rx LP	2025-06-01	HUMAN PRESCRIPTION DRUG LABEL	1