FDA.reportPublic FDA data

Tadalafil

Product NDC
69097-526
11-digit product format
690970526
Labeler code
69097
Product ID
69097-526_f5c8b23e-51e5-4264-8328-437c9d11939a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA210255
Marketing category
ANDA
Marketing start
2019-02-05
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
69097-526-03Tadalafil60 in 1 BOTTLETABLET, FILM COATED603
69097-526-16Tadalafil4 in 1 CARTONTABLET, FILM COATED43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-526-03EA - Each69097-526b05f7cbc-1228-4ac7-9b42-2c5c1f1f67fc12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-526TADALAFIL TABLET, FILM COATED [CIPLA USA INC.]3Current NDC, Legacy NDC, 2 package rows20201027_cf6fc925-ad20-4ed0-9356-15d24afa8d0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN63a6ae33-49d7-41f8-9974-d8d8058121188
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD63a6ae33-49d7-41f8-9974-d8d8058121188
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY63a6ae33-49d7-41f8-9974-d8d8058121188
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSNcf6fc925-ad20-4ed0-9356-15d24afa8d0b3
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCDcf6fc925-ad20-4ed0-9356-15d24afa8d0b3
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSYcf6fc925-ad20-4ed0-9356-15d24afa8d0b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-526-036909705260360 TABLET, FILM COATED in 1 BOTTLE (69097-526-03) 2019-02-050000-00-00NoNoCurrent
69097-526-16690970526164 TABLET, FILM COATED in 1 CARTON (69097-526-16) 2019-02-050000-00-00NoNoCurrent