FDA.reportPublic FDA data

Tadalafil

Product NDC
68180-914
11-digit product format
681800914
Labeler code
68180
Product ID
68180-914_0c0d591e-f35b-4e3d-bdcb-7d3a1c8e6a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210572
Marketing category
ANDA
Marketing start
2019-02-11
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
Tadalafil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui2123194

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
68180-914-06Tadalafil30 in 1 BOTTLETABLET, FILM COATED309
68180-914-07Tadalafil60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-914-07EA - Each68180-914823b561c-f98d-4616-b6bb-bbf18c21d2ef12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-914TADALAFIL TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20231215_efa03afa-c412-4b31-bf26-7c3a6f7311af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSNefa03afa-c412-4b31-bf26-7c3a6f7311af9
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCDefa03afa-c412-4b31-bf26-7c3a6f7311af9
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSYefa03afa-c412-4b31-bf26-7c3a6f7311af9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-914-066818009140630 TABLET, FILM COATED in 1 BOTTLE (68180-914-06) 2019-02-110000-00-00NoNoCurrent
68180-914-076818009140760 TABLET, FILM COATED in 1 BOTTLE (68180-914-07) 2019-02-110000-00-00NoNoCurrent