Tadalafil

Product NDC
68071-5272
11-digit product format
680715272
Labeler code
68071
Product ID
68071-5272_d770e7d4-9a53-2f16-e053-2a95a90a184e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209167
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5272-62022-02-07C16284748780-1d6a99b39-db11-a426-e053-dadaa90af4c2a7581142-69e5-36ec-e053-2995a90a0b99
68071-5272-62022-01-28C16284748780-1d6a99b39-db11-a426-e053-dadaa90af4c2a7581142-69e5-36ec-e053-2995a90a0b99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5272-66807152720660 TABLET, FILM COATED in 1 BOTTLE (68071-5272-6) 2020-06-050000-00-00NoNoCurrent