FDA.reportPublic FDA data

Tadalafil

Product NDC
31722-647
11-digit product format
317220647
Labeler code
31722
Product ID
31722-647_0b3039c8-da1b-416b-e063-6294a90ae7c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA209907
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
31722-647-30Tadalafil30 in 1 BOTTLETABLET303
31722-647-31Tadalafil10 in 1 BLISTER PACKTABLET103
31722-647-31Tadalafil10 in 1 CARTONTABLET103
31722-647-60Tadalafil60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-647-30EA - Each31722-647b43515ab-f751-4e1d-8a5f-7d06c5cffb9912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-647TADALAFIL (TADALAFIL) TABLET [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20231129_dc0a6a03-5ef1-4507-b888-5b559653c3e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSN8a78579b-98a6-44de-ad4e-503ab47ab56b8
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCD8a78579b-98a6-44de-ad4e-503ab47ab56b8
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSY8a78579b-98a6-44de-ad4e-503ab47ab56b8
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletPSNdc0a6a03-5ef1-4507-b888-5b559653c3e93
2123194Pulmonary Hypertension tadalafil 20 MG Oral TabletSCDdc0a6a03-5ef1-4507-b888-5b559653c3e93
2123194tadalafil 20 MG Pulmonary Hypertension Oral TabletSYdc0a6a03-5ef1-4507-b888-5b559653c3e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-647-303172206473030 TABLET in 1 BOTTLE (31722-647-30) 30 tablet2019-02-050000-00-00NoNoCurrent
31722-647-313172206473110 BLISTER PACK in 1 CARTON (31722-647-31) / 10 TABLET in 1 BLISTER PACK10 blister pack2019-02-050000-00-00NoNoCurrent
31722-647-603172206476060 TABLET in 1 BOTTLE (31722-647-60) 60 tablet2020-03-30NoNoHistorical