Tadalafil

Product NDC
68071-5182
11-digit product format
680715182
Labeler code
68071
Product ID
68071-5182_d7750696-c037-8bb2-e053-2a95a90ad1a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209907
Marketing category
ANDA
Marketing start
2019-02-05
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 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
68071-5182-42022-02-07C16284748780-1d6a99b39-6d5d-a426-e053-dadaa90af4c29f6c82d6-b8cc-c94c-e053-2995a90a9557
68071-5182-42022-01-28C16284748780-1d6a99b39-6d5d-a426-e053-dadaa90af4c29f6c82d6-b8cc-c94c-e053-2995a90a9557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5182-46807151820424 TABLET in 1 BOTTLE (68071-5182-4) 24 tablet2020-02-250000-00-00NoNoCurrent