Tadalafil

Product NDC
70934-795
11-digit product format
709340795
Labeler code
70934
Product ID
70934-795_b710c227-8195-c2a1-e053-2995a90aca6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA209167
Marketing category
ANDA
Marketing start
2020-10-16
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-795-152023-02-08C16284748780-1d6a99b39-ce7e-a426-e053-dadaa90af4c2b710d602-9332-60c7-e053-2995a90a1786
70934-795-152022-01-28C16284748780-1d6a99b39-ce7e-a426-e053-dadaa90af4c2b710d602-9332-60c7-e053-2995a90a1786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-795-157093407951515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-795-15) 2020-10-160000-00-00NoNoCurrent