Tadalafil

Product NDC
68071-5116
11-digit product format
680715116
Labeler code
68071
Product ID
68071-5116_bbf504a6-7ab9-5214-e053-2995a90a88fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209908
Marketing category
ANDA
Marketing start
2019-03-26
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5116-66807151160660 TABLET, FILM COATED in 1 BOTTLE (68071-5116-6) 2019-11-200000-00-00NoNoCurrent