ALYQ

Product NDC
0480-9277
11-digit product format
004809277
Labeler code
0480
Product ID
0480-9277_bb19ac7a-7882-4715-87e0-7bf1c30f1c62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA216932
Marketing category
ANDA
Marketing start
2024-02-20
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
ALYQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT
Rxcui2110455, 2123194

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
0480-9277-06ALYQ60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-9277-06EA - Each0480-9277c17f79db-a310-4044-9e93-c244c110c26612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-9277ALYQ (TADALAFIL) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20250105_2faa7a55-3054-456b-8465-6ea6dc1c0aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2110455ALYQ 20 MG Oral TabletPSN2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2110455Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Alyq]SBD2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2110455Alyq 20 MG Oral TabletSY2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2110455Alyq 20 MG Pulmonary Hypertension Oral TabletSY2faa7a55-3054-456b-8465-6ea6dc1c0aa95
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY2faa7a55-3054-456b-8465-6ea6dc1c0aa95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-9277-060048092770660 TABLET, FILM COATED in 1 BOTTLE (0480-9277-06) 2024-02-20NoNoHistorical