FDA.reportPublic FDA data

TADALAFIL

Product NDC
50090-7152
11-digit product format
500907152
Labeler code
50090
Product ID
50090-7152_f875882a-3457-445d-8519-d520aef273ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210609
Marketing category
ANDA
Marketing start
2022-01-18
Substance
TADALAFIL
Active strength
20 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
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui402019

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
50090-7152-0TADALAFIL30 in 1 BOTTLETABLET304
50090-7152-1TADALAFIL10 in 1 BOTTLETABLET104
50090-7152-2TADALAFIL90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7152-0EA - Each50090-7152dde773fe-0128-4a6e-9343-f5e0c7ec361812024-06-10
50090-7152-1EA - Each50090-7152eafd6dcb-bb8b-4bfe-ab98-1aecefad470512024-06-10
50090-7152-2EA - Each50090-71529db96dcc-f2ca-45b2-8cd0-bbdffd00517f12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7152TADALAFIL TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20240511_cd94158b-43fa-44fc-a858-0983770efa83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSNcd94158b-43fa-44fc-a858-0983770efa834
402019tadalafil 20 MG Oral TabletSCDcd94158b-43fa-44fc-a858-0983770efa834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7152-05009071520030 TABLET in 1 BOTTLE (50090-7152-0) 30 tablet2024-04-29NoNoHistorical
50090-7152-15009071520110 TABLET in 1 BOTTLE (50090-7152-1) 10 tablet2024-04-29NoNoHistorical
50090-7152-25009071520290 TABLET in 1 BOTTLE (50090-7152-2) 90 tablet2024-04-29NoNoHistorical