Tadalafil

Product NDC
69097-374
11-digit product format
690970374
Labeler code
69097
Product ID
69097-374_92ec5f3d-f54d-4f28-bac6-b606c99b17c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA209539
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-374-02EA - Each69097-374069042fa-4831-4504-8d89-a900fd204f7112019-04-11
69097-374-05EA - Each69097-374df0ad869-892d-415b-ac46-8a48d2e63d1e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-374TADALAFIL TABLET, FILM COATED [CIPLA USA INC.]7Legacy NDC20221226_07fc5cfc-86c9-46b9-ad5a-8d8638a3fc42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-374-026909703740230 TABLET, FILM COATED in 1 BOTTLE (69097-374-02) 2019-03-260000-00-00NoNoCurrent
69097-374-056909703740590 TABLET, FILM COATED in 1 BOTTLE (69097-374-05) 2019-03-260000-00-00NoNoCurrent
69097-374-15690970374151000 TABLET, FILM COATED in 1 BOTTLE (69097-374-15) 2019-03-260000-00-00NoNoCurrent
69097-374-94690970374942 BLISTER PACK in 1 CARTON (69097-374-94) > 15 TABLET, FILM COATED in 1 BLISTER PACK (69097-374-56) 2 blister pack2019-03-260000-00-00NoNoCurrent