TADALAFIL

Product NDC
48792-7888
11-digit product format
487927888
Labeler code
48792
Product ID
48792-7888_85105eb5-3e71-5d37-e053-2a91aa0a3ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunshine Lake Pharma Co., Ltd.
Application
ANDA211335
Marketing category
ANDA
Marketing start
2019-03-27
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7888-14879278880130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7888-1) 2019-03-270000-00-00NoNoCurrent