Tadalafil

Product NDC
51293-840
11-digit product format
512930840
Labeler code
51293
Product ID
51293-840_dd7b94f3-463d-4abd-879a-f499394ecae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ECI Pharmaceuticals, LLC
Application
ANDA210420
Marketing category
ANDA
Marketing start
2021-02-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51293-840-642023-03-22C16284748780-1f386c64a-39e5-0266-e053-dadaa90a7c1a11c2aa54-45ef-48f9-8877-e5fd2b6957ed
51293-840-642023-01-30C16284748780-1f386c64a-39e5-0266-e053-dadaa90a7c1a11c2aa54-45ef-48f9-8877-e5fd2b6957ed

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51293-840-64EA - Each51293-840f574faac-51bb-429d-bb4e-fa03c928d50012022-03-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51293-840-645129308406430 TABLET, FILM COATED in 1 BOTTLE (51293-840-64) 2021-02-010000-00-00NoNoCurrent