FDA.reportPublic FDA data

Tadalafil

Product NDC
16729-369
11-digit product format
167290369
Labeler code
16729
Product ID
16729-369_4f99c59f-9b38-f54a-e063-6294a90a60ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA209167
Marketing category
ANDA
Marketing start
2019-03-27
Substance
TADALAFIL
Active strength
2.5 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
TADALAFIL2.5 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
16729-369-10Tadalafil30 in 1 BOTTLETABLET, FILM COATED3015
16729-369-15Tadalafil90 in 1 BOTTLETABLET, FILM COATED9015
16729-369-16Tadalafil500 in 1 BOTTLETABLET, FILM COATED50015
16729-369-17Tadalafil1000 in 1 BOTTLETABLET, FILM COATED100015
16729-369-97Tadalafil2 in 1 CARTONTABLET, FILM COATED215
16729-369-97Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-369-10EA - Each16729-3691e0bbb25-d3e9-4eab-999c-b13abebe419212019-04-11
16729-369-16EA - Each16729-3697b0e143b-3e79-40b6-886a-dd1bec963e1e12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-369TADALAFIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 6 package rows20241006_eedf3ad9-7d40-496d-b1a9-6200010c18e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
757707tadalafil 2.5 MG Oral TabletPSN07567ae5-7345-4ab1-9b2c-c586c4da0427105
757707tadalafil 2.5 MG Oral TabletSCD07567ae5-7345-4ab1-9b2c-c586c4da0427105
484814tadalafil 10 MG Oral TabletPSNeedf3ad9-7d40-496d-b1a9-6200010c18e115
757707tadalafil 2.5 MG Oral TabletPSNeedf3ad9-7d40-496d-b1a9-6200010c18e115
402019tadalafil 20 MG Oral TabletPSNeedf3ad9-7d40-496d-b1a9-6200010c18e115
403957tadalafil 5 MG Oral TabletPSNeedf3ad9-7d40-496d-b1a9-6200010c18e115
484814tadalafil 10 MG Oral TabletSCDeedf3ad9-7d40-496d-b1a9-6200010c18e115
757707tadalafil 2.5 MG Oral TabletSCDeedf3ad9-7d40-496d-b1a9-6200010c18e115
402019tadalafil 20 MG Oral TabletSCDeedf3ad9-7d40-496d-b1a9-6200010c18e115
403957tadalafil 5 MG Oral TabletSCDeedf3ad9-7d40-496d-b1a9-6200010c18e115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-369-101672903691030 TABLET, FILM COATED in 1 BOTTLE (16729-369-10) 2019-03-270000-00-00NoNoCurrent
16729-369-151672903691590 in 1 BOTTLEHistorical
16729-369-1616729036916500 TABLET, FILM COATED in 1 BOTTLE (16729-369-16) 2020-05-050000-00-00NoNoCurrent
16729-369-17167290369171000 in 1 BOTTLEHistorical
16729-369-97167290369972 in 1 CARTONHistorical