ADCIRCA

Product NDC
66302-467
11-digit product format
663020467
Labeler code
66302
Product ID
66302-467_76c30323-0981-499c-b552-1a43f01c89c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
United Therapeutics Corporation
Application
NDA022332
Marketing category
NDA
Marketing start
2009-05-22
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADCIRCA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui849866, 2123194

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
66302-467-60ADCIRCA60 in 1 BOTTLETABLET6034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66302-467-60EA - Each66302-467e3cc09c6-f3cc-4e3d-9112-4d519297742012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TadalafilACTIVE INGREDIENT742SXX0ICTADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
tadalafilACTIVE MOIETY742SXX0ICTADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Ferric oxide redINACTIVE INGREDIENT1K09F3G675ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Hydroxypropyl cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
HypromellosesINACTIVE INGREDIENT3NXW29V3WOADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Magnesium stearateINACTIVE INGREDIENT70097M6I30ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
TalcINACTIVE INGREDIENT7SEV7J4R1UADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22
TriacetinINACTIVE INGREDIENTXHX3C3X673ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66302-467ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]33Current NDC, Legacy NDC, 1 package rows20241215_ff61b237-be8e-461b-8114-78c52a8ad0ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849866adcirca 20 MG Oral TabletPSNff61b237-be8e-461b-8114-78c52a8ad0ae34
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSNff61b237-be8e-461b-8114-78c52a8ad0ae34
849866Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Adcirca]SBDff61b237-be8e-461b-8114-78c52a8ad0ae34
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCDff61b237-be8e-461b-8114-78c52a8ad0ae34
849866Adcirca 20 MG Oral TabletSYff61b237-be8e-461b-8114-78c52a8ad0ae34
849866Adcirca 20 MG Pulmonary Hypertension Oral TabletSYff61b237-be8e-461b-8114-78c52a8ad0ae34
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSYff61b237-be8e-461b-8114-78c52a8ad0ae34
849866adcirca 20 MG Oral TabletPSN3ca3928a-6466-4290-a228-461fa8a917353
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN3ca3928a-6466-4290-a228-461fa8a917353
849866Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Adcirca]SBD3ca3928a-6466-4290-a228-461fa8a917353
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD3ca3928a-6466-4290-a228-461fa8a917353
849866Adcirca 20 MG Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353
849866Adcirca 20 MG Pulmonary Hypertension Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY3ca3928a-6466-4290-a228-461fa8a917353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66302-467-606630204676060 TABLET in 1 BOTTLE (66302-467-60) 60 tablet2009-08-030000-00-00NoNoCurrent
66302-467-616630204676114 TABLET in 1 BOTTLE (66302-467-61) 14 tablet2011-05-110000-00-00YesNoCurrent