FDA.reportPublic FDA data

Tadalafil

Product NDC
16714-074
11-digit product format
167140074
Labeler code
16714
Product ID
16714-074_2b1383b3-acce-43df-9aad-2d92c439b80f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA208934
Marketing category
ANDA
Marketing start
2020-02-19
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
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
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
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
16714-074-01Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED152
16714-074-02Tadalafil2 in 1 CARTONTABLET, FILM COATED22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-074-01EA - Each16714-07435b97558-e9a8-4a3c-82a6-5ecf12d1229112020-09-14
16714-074-02EA - Each16714-074a036a2a2-ca00-4c0b-95f2-941f92e5cfa412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-074TADALAFIL TABLET, FILM COATED [NORTHSTAR RXLLC]2Current NDC, Legacy NDC, 2 package rows20231111_594acc15-a5bc-43b5-9659-a864b2c46eea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
484814tadalafil 10 MG Oral TabletPSN594acc15-a5bc-43b5-9659-a864b2c46eea2
757707tadalafil 2.5 MG Oral TabletPSN30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
757707tadalafil 2.5 MG Oral TabletPSN594acc15-a5bc-43b5-9659-a864b2c46eea2
402019tadalafil 20 MG Oral TabletPSN30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
402019tadalafil 20 MG Oral TabletPSN594acc15-a5bc-43b5-9659-a864b2c46eea2
403957tadalafil 5 MG Oral TabletPSN30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
403957tadalafil 5 MG Oral TabletPSN594acc15-a5bc-43b5-9659-a864b2c46eea2
484814tadalafil 10 MG Oral TabletSCD30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
484814tadalafil 10 MG Oral TabletSCD594acc15-a5bc-43b5-9659-a864b2c46eea2
757707tadalafil 2.5 MG Oral TabletSCD30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
757707tadalafil 2.5 MG Oral TabletSCD594acc15-a5bc-43b5-9659-a864b2c46eea2
402019tadalafil 20 MG Oral TabletSCD30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
402019tadalafil 20 MG Oral TabletSCD594acc15-a5bc-43b5-9659-a864b2c46eea2
403957tadalafil 5 MG Oral TabletSCD30ae58ed-5b56-4513-8eb3-eb4f89b78f9d2
403957tadalafil 5 MG Oral TabletSCD594acc15-a5bc-43b5-9659-a864b2c46eea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-074-011671400740115 in 1 BLISTER PACKHistorical
16714-074-02167140074022 BLISTER PACK in 1 CARTON (16714-074-02) / 15 TABLET, FILM COATED in 1 BLISTER PACK (16714-074-01) 2 blister pack2020-02-190000-00-00NoNoCurrent