TADALAFIL

Product NDC
72303-0824
11-digit product format
723030824
Labeler code
72303
Product ID
72303-0824_4c53221b-7a21-9531-e063-6294a90a9ac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HEC Pharm USA Inc.
Application
ANDA211335
Marketing category
ANDA
Marketing start
2019-03-27
Substance
TADALAFIL
Active strength
10 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
TADALAFIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019, 403957, 484814, 757707

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72303-0824-1TADALAFIL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNa0f728b6-2cc6-cb65-e053-2a95a90ab1424
757707tadalafil 2.5 MG Oral TabletPSNa0f728b6-2cc6-cb65-e053-2a95a90ab1424
402019tadalafil 20 MG Oral TabletPSNa0f728b6-2cc6-cb65-e053-2a95a90ab1424
403957tadalafil 5 MG Oral TabletPSNa0f728b6-2cc6-cb65-e053-2a95a90ab1424
484814tadalafil 10 MG Oral TabletSCDa0f728b6-2cc6-cb65-e053-2a95a90ab1424
757707tadalafil 2.5 MG Oral TabletSCDa0f728b6-2cc6-cb65-e053-2a95a90ab1424
402019tadalafil 20 MG Oral TabletSCDa0f728b6-2cc6-cb65-e053-2a95a90ab1424
403957tadalafil 5 MG Oral TabletSCDa0f728b6-2cc6-cb65-e053-2a95a90ab1424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72303-0824-17230308240130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72303-0824-1) 2019-03-270000-00-00NoNoCurrent