Tadalafil

Product NDC
69097-376
11-digit product format
690970376
Labeler code
69097
Product ID
69097-376_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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-376-02EA - Each69097-376aecf37d5-991a-45aa-a46b-76c49ea421b312019-04-11
69097-376-05EA - Each69097-376ab7f83a8-688c-4d9a-b1e1-2b733349352412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-376TADALAFIL TABLET, FILM COATED [CIPLA USA INC.]7Legacy NDC20221226_07fc5cfc-86c9-46b9-ad5a-8d8638a3fc42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN995b1a68-cee4-243f-e053-2995a90a62752
402019tadalafil 20 MG Oral TabletSCD995b1a68-cee4-243f-e053-2995a90a62752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-376-026909703760230 TABLET, FILM COATED in 1 BOTTLE (69097-376-02) 2019-03-260000-00-00NoNoCurrent
69097-376-056909703760590 TABLET, FILM COATED in 1 BOTTLE (69097-376-05) 2019-03-260000-00-00NoNoCurrent
69097-376-15690970376151000 TABLET, FILM COATED in 1 BOTTLE (69097-376-15) 2019-03-260000-00-00NoNoCurrent