FDA.reportPublic FDA data

Tadalafil

Product NDC
70518-3434
11-digit product format
705183434
Labeler code
70518
Product ID
70518-3434_4f087df5-c1ba-22b4-e063-6294a90abb60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209654
Marketing category
ANDA
Marketing start
2022-06-09
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tadalafil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui403957

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3434-0Tadalafil100 in 1 BOXTABLET10011
70518-3434-1Tadalafil1 in 1 POUCHTABLET111
70518-3434-2Tadalafil250 in 1 BOXTABLET25011
70518-3434-3Tadalafil30 in 1 BOTTLE, PLASTICTABLET3011
70518-3434-4Tadalafil30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3434-4EA - Each70518-3434d94fcc97-5de6-4c49-b33f-e93a188dea8f12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3434TADALAFIL TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 5 package rows20240709_415bd983-86f3-4f38-917a-9805024f31cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403957tadalafil 5 MG Oral TabletPSN415bd983-86f3-4f38-917a-9805024f31cb11
403957tadalafil 5 MG Oral TabletSCD415bd983-86f3-4f38-917a-9805024f31cb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3434-070518343400100 POUCH in 1 BOX (70518-3434-0) > 1 TABLET in 1 POUCH (70518-3434-1) 100 pouch2022-06-090000-00-00NoNoCurrent
70518-3434-1705183434011 in 1 POUCHHistorical
70518-3434-270518343402250 POUCH in 1 BOX (70518-3434-2) / 1 TABLET in 1 POUCH (70518-3434-1) 250 pouch2022-06-230000-00-00NoNoCurrent
70518-3434-37051834340330 TABLET in 1 BOTTLE, PLASTIC (70518-3434-3) 30 tablet2022-07-280000-00-00NoNoCurrent
70518-3434-47051834340430 TABLET in 1 BOTTLE, PLASTIC (70518-3434-4) 30 tablet2023-01-03NoNoCurrent