FDA.reportPublic FDA data

Tadalafil

Product NDC
66993-700
11-digit product format
669930700
Labeler code
66993
Product ID
66993-700_2d8ed1c6-d14c-4d1e-852e-d7015d439146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021368
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-09-27
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
3 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

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
66993-700-30EA - Each66993-70007cd0fbb-d777-49d7-a8d4-147c1853d6d612018-10-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSN83040eb4-e541-499a-ae63-36534e31a94c4
403957tadalafil 5 MG Oral TabletPSN83040eb4-e541-499a-ae63-36534e31a94c4
757707tadalafil 2.5 MG Oral TabletSCD83040eb4-e541-499a-ae63-36534e31a94c4
403957tadalafil 5 MG Oral TabletSCD83040eb4-e541-499a-ae63-36534e31a94c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-700-306699307003030 TABLET, FILM COATED in 1 BOTTLE (66993-700-30) 2018-09-270000-00-00NoNoCurrent