TADLIQ

Product NDC
46287-045
11-digit product format
462870045
Labeler code
46287
Product ID
46287-045_cf6ec62b-5d5e-49ed-8d46-8a759d0e2b93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
SUSPENSION
Route
ORAL
Labeler
CMP Pharma, Inc.
Application
NDA214522
Marketing category
NDA
Marketing start
2022-08-30
Substance
TADALAFIL
Active strength
20 mg/5mL
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
TADLIQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui2613563, 2613569

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
46287-045-15TADLIQ150 mL in 1 BOTTLESUSPENSION1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46287-045-15ML - Milliliter46287-045bd68cb69-b53f-4d56-b8c7-0edb5216a1da12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46287-045TADLIQ (TADALAFIL) SUSPENSION [CMP PHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20231023_7a909b25-3772-403e-a5fe-e4a040293fb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2613563tadalafil 20 MG in 5 mL Oral SuspensionPSN7a909b25-3772-403e-a5fe-e4a040293fb76
2613569tadliq 20 MG in 5 mL Oral SuspensionPSN7a909b25-3772-403e-a5fe-e4a040293fb76
2613569tadalafil 4 MG/ML Oral Suspension [Tadliq]SBD7a909b25-3772-403e-a5fe-e4a040293fb76
2613563tadalafil 4 MG/ML Oral SuspensionSCD7a909b25-3772-403e-a5fe-e4a040293fb76
2613563tadalafil 20 MG per 5 mL Oral SuspensionSY7a909b25-3772-403e-a5fe-e4a040293fb76
2613569Tadliq 20 MG per 5 mL Oral SuspensionSY7a909b25-3772-403e-a5fe-e4a040293fb76
2613569Tadliq 4 MG/ML Oral SuspensionSY7a909b25-3772-403e-a5fe-e4a040293fb76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46287-045-1546287004515150 mL in 1 BOTTLE (46287-045-15) 150 ml2022-08-300000-00-00NoNoCurrent